[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hrher2--breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hrher2--breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,44,75,103,125,150,177,210,234,259,291,318,338,357,382,401,465,491,512,537,559],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100630820","phase-3-bgb-43395-plus-letrozole-versus-cdk46i-plus-letrozole-for-patients-with-advanced-or-metastatic-hrher2--breast-cancer-who-have-not-received-prior-treatment-for-advanced-or-metastatic-disease-100630820",false,"NCT07492641","BGB-43395 Plus Letrozole Versus CDK4\u002F6i Plus Letrozole for Patients With Advanced or Metastatic HR+\u002FHER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease","An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4\u002F6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+\u002FHER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease","KANDELA-302","Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.\n* Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Participants who have received prior systemic treatment in the advanced or metastatic setting.\n* Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},1056,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4\u002F6 inhibitor (CDK4\u002F6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.",[27],"HR+\u002FHER2- Breast Cancer",[29,30],"CDK4 inhibitor","CDK4\u002F6 inhibitor","RECRUITING","2026-06-17",{"date":34,"type":35},"2026-06-18","ACTUAL",{"date":37,"type":35},"2026-05-22",{"date":39,"type":21},"2037-08-07",{"name":41,"class":42},"BeOne Medicines","INDUSTRY",30,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100638535","phase-4-abemaciclib-dose-escalation-in-early-high-risk-breast-cancer-adjuvant-therapy-100638535","NCT07599137","Abemaciclib Dose Escalation in Early High-Risk Breast Cancer Adjuvant Therapy","Study on the Safety and Efficacy of Abemaciclib Dose Escalation Strategy in Adjuvant Therapy for Early High-Risk Breast Cancer","ADES","Inclusion Criteria:\n\n* Aged ≥18 years;\n* Pathologically confirmed breast cancer with ER and\u002For PR positive, HER2 negative;\n* Completed radical mastectomy\u002Fradiacal breast surgery;\n* Plan to receive abemaciclib combined endocrine therapy for at least 12 weeks, with abemaciclib administered via a step-up dosing regimen;\n* ECOG performance status 0-1;\n* Adequate organ function meeting medication requirements (routine blood test, liver and renal function, and other indicators consistent with clinical medication safety criteria);\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Previous exposure to any CDK4\u002F6 inhibitor;\n* Active infection or severe infection requiring systemic anti-infective treatment;\n* Significant gastrointestinal diseases such as chronic diarrhea, inflammatory bowel disease, short bowel syndrome, which may affect drug absorption or increase the risk of diarrhea;\n* Significant baseline hepatic or renal dysfunction, or uncontrolled severe comorbidities judged by the investigator to affect safety or treatment adherence;\n* Pregnancy or lactation;\n* Any other condition deemed ineligible for enrollment by the investigator.","FEMALE",{"count":54,"type":21},86,[56],"PHASE4","Abemaciclib combined with endocrine therapy has become one of the important adjuvant treatment regimens for patients with HR+\u002FHER2- high-risk early breast cancer. However, adverse events such as diarrhea, fatigue, neutropenia and elevated liver enzymes are concentrated in the early stage of adjuvant therapy, which often lead to dose reduction, temporary drug interruption or even permanent discontinuation. This further affects treatment adherence, relative dose intensity (RDI) and treatment completion rate.\n\nFindings from the TRADE study suggest that a step-up dosing strategy, initiating at a lower dose followed by gradual titration to the standard dose, combined with standardized patient education and symptomatic management, may improve early treatment tolerance, reduce the burden of partial toxicities, and increase the likelihood of patients achieving and maintaining abemaciclib 150 mg twice daily. Based on the above evidence and clinical experience, step-up dosing has been adopted by some clinicians for real-world clinical practice.\n\nNevertheless, existing evidence is mainly derived from non-Chinese populations. There is still a lack of systematic real-world data on step-up dosing among Chinese breast cancer patients under routine outpatient management, including the early toxicity profile, dose escalation achievement rate at each stage, dose adjustment pathways (prolonged escalation, treatment pause or dose de-escalation), RDI distribution, correlation with quality of life, and baseline factors affecting treatment tolerance and dose target attainment. Therefore, it is necessary to conduct a real-world study focused on Chinese patients to fill the gap in local clinical evidence, and provide a basis for clinical pathway formulation, patient education, and subsequent multicenter validation studies.",[27],[60,61,62,63],"breast cancer","Abemaciclib","Dose Escalation","side effect","NOT_YET_RECRUITING","2026-05-19",{"date":67,"type":35},"2026-05-20",{"date":69,"type":21},"2026-05-30",{"date":71,"type":21},"2028-02-01",{"name":73,"class":74},"Peking University Cancer Hospital & Institute","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":102},"100638661","phase-2-efficacy-and-safety-of-dalpiciclib-combined-with-endocrine-adjuvant-therapy-for-early-hr-her2--breast-cancer-a-multicenter-prospective-clinical-study-100638661","NCT07581834","Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +\u002FHER2- Breast Cancer: a Multicenter, Prospective Clinical Study","Inclusion Criteria:\n\n1. Female aged 18 years or older with breast cancer who are postmenopausal or premenopausal\u002Fperimenopausal.\n2. Patients with early-stage breast cancer whose HR status is positive and HER2 status is negative, as confirmed by histology (immunohistochemistry showing ER ≥10% and\u002For PR ≥10%, HER2 0-1+ or HER2 ++ but negative by FISH or CISH testing, with no amplification).\n3. Patients with histologically confirmed invasive breast cancer at clinical\u002Fpathological stages II-III.\n\n   Note: For stage IIA, N1 is required, or N0 with Grade 3 or Grade 2 tumors combined with high-risk factors such as Ki-67 ≥20% or positive genetic testing (including but not limited to high-risk results in the 21-gene test). If the patient has previously received neoadjuvant therapy, the clinical stage at the time before neoadjuvant therapy must meet the above criteria.\n4. Patients who have previously received or not received neoadjuvant chemotherapy or adjuvant chemotherapy are eligible to enroll.\n5. The time interval from surgery to enrollment must not exceed 12 months.\n6. Patients who have received radiotherapy must have recovered from the acute effects of radiotherapy, and there must be at least 14 days of washout period from the end of radiotherapy to enrollment.\n7. Patients who have previously received chemotherapy must have recovered from the acute adverse effects of chemotherapy before enrollment (\\[CTCAE\\] grade ≤1), except for hair loss or grade 2 peripheral neuropathy.There must be a washout period of at least 21 days between the last administration of chemotherapy and enrollment in the study. 8. The Eastern Cooperative Oncology Group performance status score must be 0-1. 9. The functions of major organs must meet the following requirements: a) Blood tests: neutrophils (ANC) ≥1.5×10\\^9\u002FL; platelet count (PLT) ≥90×10\\^9\u002FL; hemoglobin (Hb) ≥90 g\u002FL. b) Blood biochemistry tests: total bilirubin (TBIL) ≤2.5×ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×ULN; alkaline phosphatase ≤2.5×ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN. c) 12-lead electrocardiogram: QT interval corrected using the Fridericia method (QTcF) \\\u003C 470 ms in females (QTcF calculation formula: QTcF = QT\u002F(RR\\^1\u002F3)). Participants must voluntarily agree to participate in the study, sign the informed consent form, demonstrate good compliance, and be willing to cooperate with follow-up assessments.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer or recurrent\u002Fmetastatic breast cancer, or inflammatory breast cancer;\n2. A history of any malignant tumor, or previous receipt of anti-tumor therapy or radiotherapy for any malignant tumor, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma, etc.\n3. Participating in other clinical trials simultaneously;\n4. Received a blood transfusion within 2 weeks prior to enrollment, or received treatments such as colony-stimulating factors;\n5. Individuals with a known history of allergy to any component of this medication;\n6. A history of immunodeficiency, including a positive HIV test result, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n7. Any history of heart disease, including: (1) angina pectoris; (2) arrhythmias that require medical treatment or are clinically significant; (3) myocardial infarction; (4) heart failure; (5) any other heart disease deemed by the study investigators to be inappropriate for participation in this trial.\n8. Pregnant or lactating female patients; 9. Any other circumstances in which the researchers deem the participant unsuitable for participating in this study.",{"count":82,"type":21},2000,[84],"PHASE2","This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +\u002FHER2- early breast cancer. The study planned to include 2000 HR +\u002FHER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive\u002Fnegative), prior (neo) adjuvant chemotherapy (yes\u002Fno), and clinical\u002Fpathological stage (Stage II\u002FIII).\n\nCohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.",[87,88,89,90,91,27],"Breast Diseases","Breast Neoplasms","Dalpiciclib","Endocrine Breast Diseases","CDK4\u002F6 Inhibitor","2026-05-06",{"date":94,"type":35},"2026-05-12",{"date":96,"type":35},"2026-01-21",{"date":98,"type":21},"2032-06-30",{"name":100,"class":101},"Fujian Cancer Hospital","OTHER_GOV",2,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100611574","phase-3-marker---adjusted-therapy-comparing-adjuvant-elacestrant-with-standard-endocrine-treatment-in-genomically-andor-clinically-high-risk-erher2--ebc-100611574","NCT07242352","Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and\u002For Clinically High-risk ER+\u002FHER2- eBC","Dynamic Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and\u002For Clinically High-risk ER+\u002FHER2- Early Breast Cancer (ADAPTela)","ADAPTela","Inclusion Criteria:\n\n1. All patients, independent from gender\n2. Patient must be ≥18 years at diagnosis\n3. The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up\n4. Sign informed consent prior to any study-specific procedures.\n5. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may only be included after consultation of Sponsor.\n6. Histologically confirmed diagnosis of primary hormone-receptor-positive (HR+) (i.e., oestrogen-receptor (ER) ≥ 10% and progesterone-receptor PR ≥ 10%) early breast cancer by local laboratory Note: ER positive according to ASCO \u002F AGO Guidelines, ER 1-10% (low) is not defined as HR+.\n7. Patient has HER2-negative breast cancer defined as a negative in-situ hybridization test or an IHC status of 0, 1+, or 2+, if IHC is 2+, a negative in-situ hybridization (FISH, CISH, or SISH) test is required (based on the most recently analysed tissue sample and all tested by a local laboratory).\n8. No evidence of distant metastasis (confirmed by CT thorax \u002F abdomen, X-ray chest, ultrasound liver, bone scan, or PET-CT, respectively, performed within clinical routine).\n9. High genomic risk assessment within clinical routine (Oncotype DX® preferred; In those cases, where Oncotype Dx® is not possible in clinical routine, Oncotype Dx® should be assessed retrospectively after inclusion of the patient and as a study specific measure, provided sufficient tumour tissue from primary diagnosis is available.)\n10. 10\\. Completed 2-6 weeks of endocrine induction treatment and Ki-67 response assessment Note: 2-4 weeks recommended, up to 6 weeks allowed. Endocrine induction is highly recommended, but if endocrine induction therapy could not be performed or ET response is not representative, clinical factors should be used.\n11. 11\\. Completed (neo)adjuvant chemotherapy, if applicable\n12. Completed radiotherapy, if applicable\n13. Patient meets any of the following three conditions at end of primary treatment (including endocrine induction treatment, biopsy\u002Fsurgery, and if necessary, chemotherapy and radiotherapy and up to 12 months standard-of-care endocrine treatment, excluding previous treatment \\> 4 weeks with any SERD):\n\n    Pathological Stage \\* Genomical High-Risk (Oncotype Dx®)\\*\\* Age Clinical High-Risk Factors Stage I T1 N0\n\n    RS\\>25 Any age High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * No Chemotherapy\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS 16-25 Age \\\u003C50 High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * No Chemotherapy\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\* Any genomic risk Any age G3 and Ki-67\\>40%\n\n    Stage IIa with T2 N0\n\n    RS 0-25 Age\\>50 High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * G3 and Ki-67\\>40%\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS 0-15 Age\\\u003C50 No chemotherapy AND high risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * G3 and Ki-67\\>40%\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS 16-25 Age\\\u003C50 No chemotherapy, AND\u002FOR high risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * G3 and Ki-67\\>40%\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS \\>25 Any age Any clinical risk\n\n    Any genomic risk Any age G3 and Ki-67 \\>40%\n\n    Stage IIa with T1 N1, G1-2\n\n    RS 0-25 Age\\>50 High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n    * 3 positive LN\n\n    RS 0-25 Age \\\u003C50 No chemotherapy, AND\u002FOR high risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n    * 3 positive LN\n\n    RS\\>25 Any age Any clinical risk\n\n    Stage IIb with T3 N0 or T2 N1, G1-2 Any genomic risk Any age Any clinical risk\n\n    \\* In patients treated by neoadjuvant chemotherapy, clinical stage should be used for inclusion\n\n    \\*\\* In stage I-IIa and N0 patients with unknown genomic risk prior to inclusion, Oncotype Dx® Test should be performed on untreated tumour tissue within clinical routine.\n\n    Results of other genomic tests, if already performed within the clinical routine, may be considered. In such cases, inclusion is only possible if clinical high-risk criteria apply and after consultation with sponsor.\n\n    In those cases, where Oncotype Dx® is missing from clinical routine and in the N1-situation, Oncotype Dx® should be assessed retrospectively after inclusion of the patient and as a study specific measure, provided sufficient tumour tissue from primary diagnosis is available.\n\n    \\*\\*\\* Use of clinical factors is recommended in patients with unknown or not representative ET response.\n14. No contraindication for adjuvant SoC endocrine treatment\n15. No contraindication for elacestrant treatment\n16. No contraindication for ribociclib treatment, if medically indicated, and adequate washout time for CYP3A4 inducers\u002Finhibitors and QT time-prolonging drugs is given\n17. Tumour block for central pathology review (core biopsy of initial diagnosis and biopsy\u002Fsurgery sample of definite surgery), if available\n18. Performance Status ECOG ≤ 1 or Karnofsky Index ≥ 80%\n19. Laboratory requirements (female and male patients, not older than 14 days prior to date of informed consent)\n\n    * absolute neutrophil count ≥ 1.5 × 109\u002FL,\n    * platelets ≥ 100 × 109\u002FL,\n    * haemoglobin ≥ 9.0 g\u002FdL,\n    * INR ≤ 1.5,\n    * serum creatinine \\\u003C 1.5 × ULN OR clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n    * total bilirubin \\\u003C ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN,\n    * aspartate transaminase (AST) \\\u003C 2.5 × ULN,\n    * alanine transaminase (ALT) \\\u003C 2.5 × ULN,\n    * Screening lipid panel fasting levels: total cholesterol ≤400 mg\u002FdL AND\u002FOR triglycerides \\\u003C500 mg\u002FdL.\n\n    Note: Patients with lipid panel fasting levels NOT meeting the above criteria may consider initiating therapy for lipid management per local guidelines and will be allowed to be included once the lipid levels meet the inclusion criteria.\n20. Clinical assessments:\n\n    • normal electrocardiogram within 6 weeks prior to randomization (QTcF interval at screening \\\u003C450msec using Fridericia's correction, mean resting heart rate 50-90 bpm)\n21. Ability to swallow tablets\n22. Contraception\n\nA. Female patients of childbearing potential at inclusion must have a negative pregnancy test (serum) and additionally fulfil either one of the following conditions:\n\n* surgically sterile,\n* or carry a non-hormone releasing intrauterine device (combined with a barrier method),\n* or having received tubal ligation\u002Focclusion (combined with a barrier method),\n* or using a highly effective contraceptive method from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy; ova donation or preservation is also not allowed within this time frame\n* Total\u002Ftrue abstinence: When the patient refrains from any form of sexual intercourse and this is in line with their usual and\u002For preferred lifestyle; this must continue from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy;\n* Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia) combined with a barrier method or sexual partner with bilateral orchiectomy.\n* Hormonal contraception is not acceptable. B. Male patients must either be\n* surgically sterile\n* or using a highly effective method of contraception from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy in a partner; sperm donation or preservation is also not allowed within this time frame\n* Male patients who intend to be sexually active with a woman of childbearing potential, must use a condom plus spermicide from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy in a partner;\n* Highly effective methods of contraception should be considered in female partners of men taking elacestrant and\u002For ribociclib who are of childbearing potential.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any of the compounds or incorporated substances of the IMPs\n2. Prior malignancy with a disease-free survival of \\\u003C5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri\n3. Any history of invasive cancer within the last 10 years Note: adequately treated, basal or squamous-cell skin carcinoma, non-melanomatous skin cancer, curatively resected cervical cancer, and contralateral DCIS treated by mastectomy (contralateral in relation to current invasive breast cancer diagnosis) are excepted. Previous ipsilateral DCIS, irrespective of treatment, is excluded!\n4. Patient with distant metastases of breast cancer beyond regional lymph nodes.\n5. Concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor\n6. Concurrent treatment with other experimental drugs\n7. Participation in another interventional clinical trial with or without any investigational, not marketed drug within 30 days or 5 half-lives of the respective drug, whichever is longer, prior to study entry. In case of other interventional trial contact Sponsor.\n8. Previous treatment (\\>4 weeks) with any SERD\n9. Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment\n10. Breast feeding woman\n11. Use of oral, transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy (oestrogen or progesterone).\n12. Reasons indicating risk of poor compliance\n13. Patient not able to consent\n14. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1.\n15. Severe and relevant co-morbidity that would interact with the application of endocrine treatment of any kind or the participation in the study\n16. For patients planned for ribociclib treatment: Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n    * history of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry,\n    * documented cardiomyopathy,\n    * left ventricular ejection fraction (LVEF) \\\u003C 50 % as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO),\n    * long QT syndrome, family history of idiopathic sudden death, congenital long QT syndrome, or any of the following:\n\n      * risk factors for Torsades de Pointe (TdP, polymorphic ventricular tachycardia in patients with long QT syndrome) including uncorrected hypokalaemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002F symptomatic bradycardia,\n      * concomitant medications with a known risk to prolong the QT interval and\u002For known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug),\n      * inability to determine the QTcF interval,\n      * clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left-bundle branch block, high-grade AV block (e.g., bi-fascicular block, Mobitz type II, and 3rd-degree AV block),\n      * systolic blood pressure (SBP) \\> 160 or \\\u003C 90 mmHg.\n17. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small-bowel resection).\n18. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals\n19. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection. Patients should be tested for HIV prior to randomization if required by local regulations or ethics committee (EC). Patients who test positive for HIV-antibody are excluded.\n20. Patient has known active hepatitis-B-virus (HBV) or hepatitis-C-virus (HCV) infection. Screening for HBV or HBC-infection and testing for hepatitis-B or -C is highly recommended according to current valid (local) clinical guidelines, but neither part of the interventional study procedures, nor required for enrolment.\n21. Patient has received live vaccines within 30 days prior to randomization.\n22. Patient was submitted to an institution by virtue of an order of a court or a governmental authority must be excluded from participation.",{"count":112,"type":21},1520,[24],"In this clinical trial, the Sponsor plans to investigate whether patients with HR+\u002FHER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4\u002F6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+\u002F- CDK4\u002F6 inhibitor).\n\nBased on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4\u002F6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).",[116,27],"Breast Cancer","2026-04-29",{"date":92,"type":35},{"date":117,"type":35},{"date":121,"type":21},"2033-09-30",{"name":123,"class":74},"West German Study Group",1,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100592820","phase-1-orion-1-study-of-avzo-023-as-a-single-agent-and-in-combination-with-avzo-021-andor-endocrine-therapy-in-advanced-solid-tumors-100592820","NCT06998407","ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and\u002For Endocrine Therapy in Advanced Solid Tumors","A Phase 1\u002F2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and\u002For Endocrine Therapy in Patients With Advanced Solid Tumors","AVZO-023-1001","Key Inclusion Criteria:\n\n* Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy \\> 3 months\n* Patients with histologically or cytologically proven advanced malignancies of preferred indications\n* Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. Bone only disease is allowed in dose escalation.\n* Agree to provide molecular test report results to confirm eligibility and archival tumor samples and\u002For fresh biopsy, as applicable\n* Adequate renal, liver, and bone marrow function\n\nKey Exclusion Criteria:\n\n* Patients should not have received any prior selective investigational CDK (CDK2, CDK4, CDK2\u002F4, CDK2\u002F4\u002F6) inhibitors\n* Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease\n* Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps\n* Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study\n* Major surgery within 4 weeks prior to first dose on study\n* Have received radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have active radiation pneumonitis\n* Strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose on study\n* History of serious cardiovascular conditions within 6 months prior to first dose on study\n* Unresolved toxicities from prior therapy greater than Grade 1 (per CTCAE version 5.0) (with exceptions of alopecia, vitiligo, and ≤ Grade 2 peripheral neuropathy) prior to the first dose on study\n* History of drug-induced pneumonitis\u002Finterstitial lung disease\n* Confirmed loss of function mutation or deletion of Rb1 gene",{"count":134,"type":21},380,[136,84],"PHASE1","This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).",[27,139],"HR+, HER2-, Advanced Breast Cancer","2026-04-28",{"date":142,"type":35},"2026-05-04",{"date":144,"type":35},"2025-08-20",{"date":146,"type":21},"2030-08",{"name":148,"class":42},"Avenzo Therapeutics, Inc.",14,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":124},"100634443","phase-2-brain-radiotherapy-combined-with-dalpiciclib-and-endocrine-therapy-in-hr-positiveher2-negative-advanced-breast-cancer-with-brain-metastases-100634443","NCT07539753","Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive\u002FHER2-Negative Advanced Breast Cancer With Brain Metastases","A Single-Arm, Phase II Study of Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive\u002FHER2-Negative Advanced Breast Cancer Patients With Brain Metastases","Inclusion Criteria:\n\n* 1.Female patients aged 18 to 75 years, who are postmenopausal or premenopausal\u002Fperimenopausal, and meet at least one of the following conditions:\n\n  1. prior bilateral oophorectomy; or age ≥60 years; or\n  2. age \\\u003C60 years and postmenopausal status defined as at least 12 consecutive months of spontaneous amenorrhea without other pathological or physiological causes, with estradiol (E2) and follicle-stimulating hormone (FSH) levels within the postmenopausal range; or\n  3. premenopausal or perimenopausal women are also eligible if they are willing to receive treatment with an LHRH agonist during the study.\n* 2.Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer in female patients, with evidence of locally recurrent or metastatic disease that is not amenable to curative surgery or radiotherapy, and with no clinical indication for chemotherapy.\n* HR-positive is defined as ER-positive and\u002For PR-positive, with ≥1% of tumor cells showing positive staining, as confirmed by the investigator at the study site.\n* HER2-negative is defined as IHC 0 or 1+, or ISH-negative, defined as a HER2\u002FCEP17 ratio \\\u003C2.0 or an average HER2 copy number \\\u003C4.0, as confirmed by the investigator at the study site.\n* 3.Presence of brain metastases confirmed by MRI, with at least one measurable intracranial lesion ≥1 cm according to RECIST version 1.1. Measurable extracranial disease is not required.\n* 4.ECOG performance status 0-2, and an estimated life expectancy of at least 12 weeks at the time of enrollment.\n* 5.If the patient is receiving corticosteroids, the corticosteroid dose must be stable or decreasing for at least 5 days before the brain gadolinium-enhanced MRI (Gd-MRI). This MRI must be performed within 28 days before enrollment. Patients who require an increased steroid dose before treatment, or who are receiving an unstable steroid dose, are not eligible.\n* 6.Screening laboratory values must meet the following criteria( and should be obtained within 14 days prior to registration)::\n\n  1. absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³ (1.5 × 10\\^9\u002FL), without growth factor support within 14 days;\n  2. platelet count (PLT) ≥ 100,000\u002Fmm³ (100 × 10\\^9\u002FL), without corrective treatment within 7 days;\n  3. hemoglobin (Hb) ≥ 9 g\u002FdL (90 g\u002FL), without corrective treatment within 7 days;\n  4. serum creatinine (Scr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 60 mL\u002Fmin;\n  5. total bilirubin ≤ 1.5 × ULN;\n  6. aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × ULN, or ≤ 5 × ULN for patients with liver metastases.\n* 7.Prior stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) is permitted, provided that the currently active measurable disease has not been previously treated with radiotherapy.\n* 8.Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and must agree to use a medically acceptable highly effective method of contraception during the study and for 1 year after the last dose of study treatment.\n* 9.Ability and willingness to signed the informed consent form prior to patient entry.\n\nExclusion Criteria:\n\n* 1.Prior pathological diagnosis of HER2-positive breast cancer.\n* 2.Prior disease progression on dalpiciclib in the metastatic setting.\n* 3.Primary endocrine resistance, defined as either:\n\n  1. disease recurrence or progression within 2 years of starting adjuvant endocrine therapy; or\n  2. disease progression within 6 months of first-line endocrine therapy for advanced or metastatic disease.\n* 4.Patients considered not suitable for endocrine therapy in the judgment of the investigator, including patients with symptomatic visceral disease, disseminated visceral involvement, or a risk of life-threatening complications in the short term, such as uncontrolled massive effusions (pleural, pericardial, or peritoneal), lymphangitic carcinomatosis of the lung, or \\>50% liver involvement.\n* 5.Presence of leptomeningeal metastases.\n* 6.Prior whole-brain radiotherapy (WBRT) .\n* 7.Any severe neurologic symptoms caused by central nervous system metastases.\n* 8.Pregnant or breastfeeding women.\n* 9.Any serious uncontrolled clinical disease or infection that, in the investigator's judgment, cannot be adequately controlled with appropriate treatment or may impair the patient's ability to tolerate study treatment, including but not limited to:\n\n  1. serious cardiovascular events such as syncope of cardiovascular origin, pathologic ventricular arrhythmias (including but not limited to ventricular tachycardia or ventricular fibrillation), or cardiac arrest;\n  2. end-stage renal disease;\n  3. severe liver disease;\n  4. active systemic bacterial infection.\n* 10.History of immunodeficiency, including HIV infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, other acquired or congenital immunodeficiency disorders, or prior organ transplantation.\n* 11.History of malignancy other than breast cancer.\n* 12.Inability to swallow oral medication, or presence of chronic diarrhea, intestinal obstruction, or other conditions that may interfere with the administration or absorption of study drugs.\n* 13.History of allergy or hypersensitivity to any study drug or any of its components.","75 Years",{"count":159,"type":21},46,[84],"This is a prospective, open-label, exploratory clinical trial designed to evaluate the efficacy and safety of brain radiotherapy combined with dalpiciclib and endocrine therapy in HR-positive\u002FHER2-negative advanced breast cancer patients with brain metastases. A total of 46 patients are planned to be enrolled.\n\nParticipants will receive dalpiciclib plus endocrine therapy and brain radiotherapy, including fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the clinical characteristics of brain metastatic lesions. Radiotherapy may start within 30 days before or after initiation of drug treatment. Dalpiciclib and endocrine therapy may be given concurrently during radiotherapy and will be continued after radiotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator decision. Participants will visit the clinic once every 3 months for checkups and tests. Tumor response will be assessed according to RECIST version 1.1, and safety will be evaluated throughout the study.",[116,163,27],"Brain Metastases",[27,165,166,167],"brain metastases","brain radiotherapy","dalpiciclib","2026-04-24",{"date":170,"type":35},"2026-04-30",{"date":172,"type":21},"2026-06-01",{"date":174,"type":21},"2029-08-01",{"name":176,"class":74},"Nanfang Hospital, Southern Medical University",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":52,"minAge":185,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":194,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100601141","phase-3-optimising-adjuvant-chemotherapy-prescription-in-young-patients-with-hormone-dependent-breast-cancer-using-genomic-tests-100601141","NCT07106632","Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests","Optimal Personalized Treatment of Early Breast Cancer Using Multi-parameter Analysis: Focus on YOUNGer Women","OPTIMA-YOUNG","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;\n2. . Premenopausal defined by patient that are not post-menopaused\n3. Female\n4. Age ≥ 35 years\n5. Diagnosis of invasive HR-positive (ER≥10% of tumour cells stained positive and any PR expression) HER2-negative (IHC score 0-1+ or 2+ with negative\u002Fnon-amplified ISH) invasive breast cancer; ER and HER2 determination will be assessed according to latest ASCO\u002FCAP or national guidelines;\n6. Breast and axillary surgery completed ≤ 12 weeks from study entry and randomization;\n7. Availability of a Formalin-Fixed Paraffin-Embedded (FFPE) tumour sample from surgery to perform Prosigna® analysis or slides.\n\n   Note: in case of receipt of neoadjuvant endocrine therapy the Prosigna® test must be done on the baseline biopsy. Performing the test on the surgical piece or on on-treatment biopsy is not permitted.\n8. Tumour size and axillary lymph node status. One of the following must apply:\n\n   1. 1-3 lymph nodes involved AND any invasive tumour size.\n   2. node negative (including micrometastases in at least 1 node \\[i.e. deposit \\>0.2-2mm diameter\\]) AND invasive tumour size ≥ 50mm.\n9. Multiple ipsilateral breast cancers are permitted provided that at least one tumour meets the tumour size and axillary lymph node entry criteria, and none meet any of the exclusion criteria.\n10. Bilateral breast cancers are permitted provided the tumour(s) in one breast meets the eligibility criteria and the other, contralateral tumour is not ER negative and\u002For HER2 positive and not clinically significant, defined by both of the following:\n\n    1. The contralateral tumour does not fulfil the tumour size and lymph node eligibility criteria required for trial entry; i.e. the following are not acceptable:\n\n       .i. presence of lymph node macro-metastases; .ii. tumour size ≥50mm when there is no lymph node involvement.\n    2. The treating physician does not consider that the characteristics of the contralateral tumour alone justify consideration of adjuvant chemotherapy.\n11. Fitness to receive adjuvant chemotherapy, as judged by the treating physician;\n12. Short term pre-surgical treatment with endocrine therapy, including in combination with non-cytotoxic agents, is allowed providing that the duration of treatment did not exceed 8 weeks;\n13. Patients affiliated with or a beneficiary of the local social security system, health social security system, or other local regulatory requirements\n14. Patients must agree to use adequate contraception methods for the duration of study treatment and for the duration specified in the SmPC after completing the treatment, unless agreed with the treatment physician the safety of attempt a pregnancy, which could be possible after at least 18 months of endocrine therapy.\n\nNote : patient with extracapsular nodular transgression are eligible. NOTE: If neoadjuvant endocrine therapy was received, the Prosigna® test must be realized on the baseline biopsy. Performing the test on the surgical specimen or on biopsy taken during treatment is not permitted.\n\nNOTE: Re-excision or complementary mastectomy for close\u002Fpositive surgical margins should be postponed after chemotherapy completion, if chemotherapy is given; breast reconstruction is allowed after trial entry.\n\nNOTE: The use of approved adjuvant targeted agents (abemaciclib, ribociclib and olaparib) combined to adjuvant endocrine therapy is allowed according to local practice recommendations and availability.\n\nExclusion Criteria:\n\n* 1\\. Postmenopausal women. Women who fulfil the following criteria at trial entry will be considered postmenopausal:\n\n  1. Age \\>45 and natural amenorrhoea of at least 1 year's duration.\n  2. Bilateral surgical oophorectomy.\n  3. For amenorrhoea not fulfilling the above criteria the diagnosis of postmenopausal status should be supported by hormone measurement: FSH levels must be \\> 25IU\u002FL with low oestradiol (i.e. within the locally defined postmenopausal range), in the event of doubt measured on 2 occasions preferably 4-6 weeks apart. This applies to women who have undergone hysterectomy without bilateral surgical oophorectomy and are age \\\u003C60; those ≥60 may be considered postmenopausal.\n\n     NOTE: Hormonal contraception will suppress FSH and oestradiol levels. In those taking oral contraception, levels will recover rapidly on discontinuation. Depo-Provera injectable contraception lasts many months: all women receiving this agent should be considered premenopausal.\n\n     2\\. Stage IV breast cancer; 3. Start of adjuvant systemic treatment (except for neoadjuvant endocrine therapy for a duration ≤ 8 weeks) before trial entry\\*; 4. Previous diagnosis of malignancy except:\n\n  \u003C!-- -->\n\n  1. Previous ductal carcinoma in situ (DCIS) or pleomorphic lobular carcinoma in situ (LCIS) of the breast managed by local treatment only;\n  2. Previous in situ carcinoma as defined by the International Classification of Diseases for Oncology (ICD-O) including basal cell carcinoma of skin and cervical intraepithelial neoplasia;\n  3. Previous invasive malignancy managed by local treatment only AND disease-free for at least 10 years.\n\n     5\\. Patients enrolled in another therapeutic trial within 30 days of inclusion; 6. Presence of concomitant medical and\u002For psychiatric comorbidities and\u002For social problems that might prevent informed consent, treatment compliance or follow up; 7. Person deprived of their liberty or under protective custody or guardianship.\n\n     8\\. Pregnant women or women who are breast-feeding at inclusion. 9. Patients unwilling or unable to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures because of geographic, familial, social, or psychological reasons.\n\n     \\*Trial entry is dated from of the date the participant signs the consent form or provides remote verbal consent, whichever is earlier.","35 Years","45 Years",{"count":188,"type":21},3380,[24],"Rationale:\n\nAround 70 to 80% of breast cancers are so-called \"hormone-dependent\" (HR+)\u002FHER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug associated with ovarian suppression (OFS), improve survival in patients with these cancers, which are characterised by a high risk of relapse. However, younger patients suffer more side effects than older women, particularly from chemotherapy. This can affect their quality of life and reduce their ability to work.\n\nFor post-menopausal women, genetic tests exist to assess whether chemotherapy is really necessary in addition to hormonal treatment. However, for high-risk premenopausal patients, chemotherapy is still systematically recommended, as no study has proved that it can be safely avoided. Clinical trials based on risk stratification using genetic tests have not been conclusive, but the majority of premenopausal women included had not received optimal hormone treatment. It is possible that the beneficial effect of chemotherapy is partly due to the artificial menopause it induces. Some experts believe that, for patients with a high clinical risk but a low genetic risk, an optimised hormonal treatment (drug + OFS) could suffice, without the need for chemotherapy.\n\nObjectives:\n\nMain objective: The aim of the study is to determine whether the use of a genetic test (Prosigna®) to decide whether or not to administer chemotherapy produces results as good as standard treatment (systematic chemotherapy) in premenopausal women with hormone-dependent (HR+) breast cancer\u002FHER2-, by assessing their risk of cancer recurrence.\n\nThe secondary objectives include verifying whether, in patients with a low Prosigna® score (around 70% of cases), optimised hormonal treatment (including suppression of ovarian function) is as effective as chemotherapy combined with hormonal in treatment preventing cancer recurrence. The study also seeks to compare the efficacy of treatment Prosigna®-guided versus systematic chemotherapy in terms of recurrence and quality of life, as well as economic aspects. Finally, the aim is to understand patients' concerns about the concept of reducing treatment (therapeutic de-escalation) and the way in which this information is communicated to them.\n\nThe primary endpoint of the study is to measure the time elapsed between the start of participation in the study and the appearance of an event indicating a return of the cancer. This includes the return of cancer in the same breast or neighbouring areas, the spread of cancer to other parts of the body, the appearance of new cancer in the other breast or death from any cause.\n\nTrial Population:\n\nThe study includes women major premenopausal diagnosed with invasive, hormone receptor-positive (ER+) and HER2-negative breast cancer. Patients must have undergone breast and axillary surgery recent and have a tumour sample suitable for analysis by the testProsigna® . They must be able to receive the study treatments Postmenopausal women, women with stage IV breast cancer, women who have already received adjuvant systemic treatment (except short neoadjuvant hormone therapy), women with a recent history of invasive cancer, pregnant women or women who are breast-feeding will not be able to take part in the study.\n\nInterventions:\n\nAfter agreeing to take part, patients will enter the pre-inclusion period (up to 28 days before randomisation), during which the investigator will carry out all the necessary tests to assess their eligibility. The investigator will then randomise the patients to find out which treatment they have been assigned, no more than 2 weeks later: the experimental group will receive a treatment decided on the basis of the results of a genomic test: either chemotherapy and hormone therapy, or hormone therapy alone. The control group will receive the standard treatment. The treatment and follow-up phases are the same as for standard care. Information on the quality of life patient's will and other information (associated costs, perception of their participation in the study, etc.) also be collected by means of questionnaires completed by the patients during the 5 years following randomisation.",[192,193,27],"Early Breast Cancer","Premenopausal Breast Cancer",[195,196,197,198,199],"Adjuvant therapy de-intensification","Care delivery","Quality of Life","Premenopausal Women","Risk stratification","2026-03-23",{"date":202,"type":35},"2026-03-24",{"date":204,"type":21},"2026-04-01",{"date":206,"type":21},"2038-08-15",{"name":208,"class":74},"UNICANCER",105,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":222,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":124},"100590414","phase-2-ql1706-for-the-neoadjuvant-treatment-of-hrher2--breast-cancer-100590414","NCT06967103","QL1706 for the Neoadjuvant Treatment of HR+\u002FHER2- Breast Cancer","QL1706 Combined With PE Compared With PE for the Neoadjuvant Treatment of HR+\u002FHER2- Breast Cancer","Inclusion Criteria\n\nSubjects meeting all of the following criteria are eligible for inclusion in this study:\n\nVoluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.\n\nFemale, aged ≥18 years .\n\nEvaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.\n\ncT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；\n\nHistologically and\u002For cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor \\[ER\\] or progesterone receptor \\[PR\\] nuclear staining \\>1%) with Ki67 ≥20%.\n\nHER2-negative breast cancer, defined as:\n\nNegative in situ hybridization (ISH) results; or\n\nImmunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative.\n\nWilling to provide fresh or archived tumor tissue samples.\n\nAt least one measurable lesion per RECIST 1.1 criteria.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nAdequate organ function, defined as:\n\nHematology:\n\nHemoglobin ≥90 g\u002FL\n\nAbsolute neutrophil count ≥1.5 × 10⁹\u002FL\n\nPlatelet count ≥100 × 10⁹\u002FL.\n\nBiochemistry:\n\nALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present);\n\nTotal bilirubin ≤1.5 × ULN;\n\nSerum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL\u002Fmin.\n\nCoagulation:\n\nActivated partial thromboplastin time (APTT) ≤1.5 × ULN;\n\nInternational normalized ratio (INR) ≤1.5 × ULN.\n\nCardiac function:\n\nLeft ventricular ejection fraction (LVEF) ≥50% by echocardiography.\n\nPremenopausal or perimenopausal subjects must agree to use reliable and effective contraception or practice abstinence from the time of informed consent until at least 90 days after the last dose of study treatment.\n\nExclusion Criteria\n\nSubjects meeting any of the following criteria will be excluded from this study:\n\nKnown severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients.\n\nStage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator.\n\nInflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma).\n\nMajor surgery or significant trauma within 28 days prior to the first dose.\n\nAdministration of live attenuated vaccines within 28 days before the first dose or anticipated during the study.\n\nSystemic corticosteroids or immunosuppressive therapy within 14 days prior to the first dose or anticipated during the study.\n\nActive autoimmune disease requiring systemic treatment within 2 years prior to enrollment, or history of autoimmune disorders.\n\nSevere systemic infection within 28 days or active infection requiring intravenous\u002Foral antibiotics within 14 days prior to the first dose.\n\nPrior organ or allogeneic bone marrow transplantation or awaiting transplantation.\n\nHistory or evidence of interstitial lung disease or active non-infectious pneumonitis.\n\nBleeding tendency or high risk of hemorrhage.\n\nThromboembolic events (e.g., cerebrovascular accident, pulmonary embolism) within 6 months prior to enrollment.\n\nCongenital or acquired immunodeficiency (e.g., HIV infection).\n\nActive hepatitis:\n\nHepatitis B: HBsAg-positive with HBV DNA ≥2000 IU\u002FmL;\n\nHepatitis C: HCV antibody-positive with HCV RNA above the upper limit of normal.\n\nPoorly controlled cardiac conditions, including:\n\nNYHA Class II or higher heart failure or LVEF \\\u003C50%;\n\nUnstable angina;\n\nMyocardial infarction within 1 year;\n\nQTc interval \\>470 ms (female) on resting ECG.\n\nOther malignancies within 5 years (excluding basal cell carcinoma or cervical carcinoma in situ).\n\nUse of investigational drugs within 4 weeks prior to the first dose.\n\nHistory or current diagnosis of neurological or psychiatric disorders (e.g., epilepsy, dementia).\n\nHistory of pancreatitis.\n\nPregnancy, lactation, or refusal to use contraception.\n\nAny other condition deemed inappropriate for participation by the investigator.",{"count":218,"type":21},238,[84],"The goal of this clinical trial is to learn if QL1706 is effective in early HR+\u002FHER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are:\n\nDoes QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+\u002FHER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.",[116,27],[223,224,60],"PD1","CTLA4","2026-01-07",{"date":227,"type":35},"2026-01-08",{"date":229,"type":35},"2025-09-08",{"date":231,"type":21},"2029-05-30",{"name":233,"class":101},"Henan Cancer Hospital",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":157,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":124},"100612536","phase-2-combined-chemo-immunotherapy-plus-sbrt-in-neoadjuvant-treatment-for-luminal-subtype-breast-cancer-100612536","NCT07254858","Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer","Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer: A Prospective Multicenter Randomized Controlled Trial","CISN-L","Inclusion Criteria:\n\n1. Newly diagnosed, untreated breast cancer;\n2. Age: 18 years ≤ age ≤ 75 years;\n3. Histologically confirmed hormone receptor-positive (HR+) tumor specimen (estrogen receptor \\[ER\\] ≥ 10%);\n4. Human epidermal growth factor receptor-2 immunohistochemistry (HER2-IHC) result of 0\u002F1+ or 2+ with negative fluorescence in situ hybridization (FISH) test;\n5. Histologically confirmed cell proliferation index (Ki67) ≥ 20%;\n6. Programmed death-ligand 1 combined positive score (PD-L1 CPS) evaluable (i.e., availability of fresh\u002Farchived specimens);\n7. Good pulmonary function;\n8. Adequate hepatic and renal function;\n9. Histological grade ≥ 2;\n10. cN0, cT ≥ 3 cm or cN1-3, cT ≥ 2 cm (cT: clinically assessed maximum diameter of primary tumor; cN: clinically assessed regional lymph node status);\n11. Eastern Cooperative Oncology Group Performance Status (ECOG score) 0-1. Exclusion Criteria:\n\n1.Pregnancy; 2.Tumor \\> 8 cm with skin ulceration; 3.History of thoracic radiotherapy or contraindications to radiotherapy; 4.Active autoimmune disease; 5.Prior use of PD-L1 antibody therapy; 6.De novo breast cancer; 7.There are factors that may significantly increase the risk of lung or cardiac toxicity related to radiotherapy, such as (1) maximum lung depth(MLD) \\>3.2cm； (2) maximum heart distance(MHD) \\\u003C2.4cm。",{"count":243,"type":21},302,[84],"This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy in the neoadjuvant treatment of high-risk HR+\u002FHER2- breast cancer patients.\n\nThe study plans to enroll treatment-naïve HR+\u002FHER2- breast cancer patients aged 18-75 with high-risk features (e.g., tumor size ≥3 cm or lymph node positivity, Ki-67 ≥20%). Eligible subjects will be randomized in a 1:1 ratio into two groups: the control group will receive neoadjuvant chemotherapy (nab-paclitaxel followed by epirubicin + cyclophosphamide) in combination with sintilimab immunotherapy; the experimental group will receive the same chemotherapy and immunotherapy regimen with the addition of stereotactic body radiotherapy (SBRT) administered early during treatment, at a prescribed dose of 8 Gy per fraction for 3 fractions, with one fraction per day.\n\nThe study has dual primary endpoints: pathological complete response (pCR,) and objective response rate (ORR ). Secondary endpoints include 3-year event-free survival (EFS), incidence of adverse events (CTCAE v5.0), and postoperative cosmetic outcomes of the breast. The study design incorporates hierarchical testing to control for multiplicity, and long-term follow-up is planned to evaluate survival benefits.\n\nThe study has been approved by the ethics committee, and all participants are required to provide written informed consent. The results are expected to offer a novel neoadjuvant treatment strategy for high-risk HR+\u002FHER2- breast cancer patients and improve their therapeutic outcomes.",[27],[116,248,249],"Radiotherapy","Immunotherapy","2025-11-20",{"date":252,"type":35},"2025-11-28",{"date":254,"type":21},"2025-12",{"date":256,"type":21},"2029-12-30",{"name":258,"class":74},"First Affiliated Hospital of Wenzhou Medical University",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":278,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100505889","phase-1-study-of-avzo-021-in-patients-with-advanced-solid-tumors-100505889","NCT05867251","Study of AVZO-021 in Patients With Advanced Solid Tumors","A Phase 1\u002F2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.\n2. Disease-related inclusion criteria by study phase and part:\n\n   i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+\u002FHER2- breast cancer, CCNE1-amplified tumors that are either epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor. Patients with any additional tumor type with CCNE1 amplification can be enrolled only if clinical data is supportive and approved by medical monitor (Cohort 1A).\n\n   ii) Phase 1b Combination Dose Escalation: histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+ HER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer, who have been previously treated with inhibitor of CDK4\u002F6 and endocrine therapy(Cohorts 1B1, 1B2, 1B3, 1B4, and 1B5); or histologically or cytologically confirmed diagnosis of CCNE1- amplified, locally advanced or metastatic, platinum-refractory or platinum-resistant EOC, primary peritoneal, or fallopian tube cancer (Cohort 1C).\n\n   iii) Phase 2a Monotherapy dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic CCNE1 amplified epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor (Cohort 2A).\n\n   iv) Phase 2b Combination dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+\u002FHER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer who have been previously treated with no more than 1 prior CDK4\u002F6 inhibitor and endocrine therapy (Cohorts 2B1, 2B2, 2B3, 2B4, and 2B5); or Histologically or cytologically confirmed diagnosis of locally advanced or metastatic, CCNE1-amplified, platinum-refractory or platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer (Cohort 2C).\n3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced\u002Fmetastatic disease (excepting patients treated with an antibody-drug conjugate, with ovarian cancer if there disease is platinum resistant or refractory, having progressed beyond all SOC care; and patients who have received prior chemotherapy in the adjuvant or neoadjuvant setting \\>12 months prior to starting AVZO-021 treatment).\n4. Measurable disease as determined by RECIST version 1.1.\n5. Adequate bone marrow and organ function.\n6. Ability to swallow capsules or tablets.\n\nKey Exclusion Criteria:\n\n1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.\n2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine\u002Fthreonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted.\n3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.\n4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.\n5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.\n6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \\>1 at the time of starting study treatment.\n7. Clinically unstable cardiac function as described in the protocol.\n8. Any active or chronic infection\u002Fdisease that compromises the immune system.\n9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.\n10. Active second malignancy unless in remission with life expectancy \\> 2 years and with documented sponsor approval.\n11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.",{"count":267,"type":21},430,[136,84],"This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).",[271,27,139,272,273,274,275,276,277],"Advanced Solid Tumor","CCNE1 Amplification","Epithelial Ovarian Cancer","Primary Peritoneal Cancer","Fallopian Tube Cancer","Endometrial Cancer","TNBC - Triple-Negative Breast Cancer",[279,27,116,280,272,273,274,275,276,281],"Advanced solid tumor","Advanced Breast Cancer","Triple Negative Breast Cancer","2025-11-17",{"date":284,"type":35},"2025-11-19",{"date":286,"type":35},"2023-08-30",{"date":288,"type":21},"2030-01-31",{"name":148,"class":42},13,{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":157,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100583331","phase-2-neoadjuvant-chemotherapy-in-combination-with-anlotinib-and-benmelstobart-for-hrher2--breast-cancer-neotorch-breast03-100583331","NCT06874933","Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+\u002FHER2- Breast Cancer (NEOTORCH-BREAST03)","A Prospective, Single-Arm Clinical Study on the Treatment of HR+\u002FHER2- Breast Cancer With Neoadjuvant Chemotherapy Combined With Anlotinib and Benmelstobart Monoclonal Antibody","Inclusion Criteria:\n\n1. Female patients aged between 18 and 75 years old.\n2. With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n3. Patients with histologically or pathologically confirmed invasive ductal carcinoma of the breast, and simultaneously meeting the following conditions:\n\n   T1c (≥1 cm) - 4c N0-2; Histologically confirmed as grade 3 by the research center; Immunohistochemical staining results confirm ER+ (≥1%), HER2 negative (Her2\u002Fneu fluorescence in situ hybridization (FISH) ratio ≤ 1.8 or IHC 0 or 1+); and the combined positive score (CPS) is greater than or equal to 10 points. The PD-L1 antibody site detected in our center is 22C3.\n\n   Have not received any previous treatment.\n4. The functional levels of the major organs must meet the following requirements (no blood transfusion, and no use of drugs for increasing white blood cells or platelets within 2 weeks before screening):\n\n   1. Blood routine: Absolute neutrophil count (ANC) \\> 1.5×10⁹\u002FL; platelet count (PLT) \\> 75× 10⁹\u002FL; hemoglobin (Hb) \\> 90 g\u002FL; lymphocyte count ≥ 1.5×10⁹\u002FL.\n   2. Blood biochemistry: Total bilirubin (TBIL) \\\u003C 1.5× the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 1.5×ULN; alkaline phosphatase \\\u003C 2.5×ULN; blood urea nitrogen\u002Furea (BUN\u002FUREA) and creatinine (Cr) \\\u003C 1.5×ULN.\n   3. Echocardiogram: Left ventricular ejection fraction (LVEF) \\> 55%.\n   4. 12-lead electrocardiogram: The corrected QT interval using the Fridericia method (QTcF) \\\u003C 470 msec.\n5. For premenopausal female patients or those who have not undergone surgical sterilization: Use an effective contraceptive method during the treatment period and for at least 6 months after the last administration of the study treatment.\n6. Voluntarily participate in this study, sign the informed consent form, have good compliance, and be willing to cooperate with the follow-up.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer.\n2. Inflammatory breast cancer.\n3. Have previously received anti-tumor treatment or radiotherapy for any malignant tumor, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma.\n4. Simultaneously receiving anti-tumor treatment in other clinical trials, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone-modifying drug therapy, or immune checkpoint inhibitor therapy.\n5. Having undergone a major surgical procedure unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such a surgical procedure.\n6. Severe heart diseases or disorders, including but not limited to the following diseases:\n\n   A confirmed history of heart failure or systolic dysfunction (left ventricular ejection fraction \\[LVEF\\] less than 50%).\n\n   High-risk uncontrolled arrhythmias, such as atrial tachycardia with a resting heart rate greater than 100 beats per minute (bpm), significant ventricular arrhythmias (such as ventricular tachycardia), or higher-degree atrioventricular block (i.e., Mobitz type II second-degree atrioventricular block or third-degree atrioventricular block).\n\n   Angina pectoris requiring treatment with anti-anginal drugs. Clinically significant valvular heart disease. Electrocardiogram (ECG) showing transmural myocardial infarction. Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and\u002For diastolic blood pressure greater than 100 mmHg after drug treatment).\n7. Uncontrolled active infections that require treatment; a history of immunodeficiency, including a positive HIV test result, or suffering from other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n8. Patients with active chronic hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, patients with stable hepatitis B after drug treatment \\[negative HBV-DNA test or \\\u003C 50 IU\u002Fml\\], and cured hepatitis C patients \\[negative HCV RNA test\\]).\n9. Have previously received immunotherapy and experienced immune-related adverse events such as immune-related pneumonia or myocarditis, which, as determined by the investigator, may affect the safety of the study drug.\n10. Known history of allergy to the components of this treatment regimen.\n11. Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test result, or patients of childbearing age who are unwilling to use effective contraceptive measures throughout the trial period and within 6 months after the last administration of the study drug.\n12. Suffering from severe concomitant diseases or other comorbidities that may interfere with the planned treatment, or any other situation in which the investigator deems the patient unsuitable for participating in this study.",{"count":299,"type":21},35,[84],"Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+\u002FHER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy de-escalation for patients with HR+\u002FHER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+\u002FHER2- breast cancer.",[27],[304,305,306,307],"Breast cancer","Anlotinib and Benmelstobart","Adjuvant Chemotherapy","HR-positive HER2-negative","2025-08-11",{"date":310,"type":35},"2025-08-12",{"date":312,"type":35},"2025-05-04",{"date":314,"type":21},"2030-04-01",{"name":316,"class":74},"First Affiliated Hospital of Zhejiang University",3,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":157,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":337},"100563103","phase-2-neoadjuvant-chemotherapy-in-combination-with-toripalimab-for-hrher2--breast-cancer-neotorch-breast01-100563103","NCT06611813","Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+\u002FHER2- Breast Cancer (NEOTORCH-BREAST01)","Neoadjuvant Chemotherapy Combined With Toripalimab for HR+\u002FHER2- Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST01)","Inclusion Criteria:\n\n1. Female patients aged 18-75 years old;\n2. ECOG score is 0-1 points;\n3. breast cancer meets the following standards: Histologically confirmed invasive breast cancer with tumor diameter\\>1cm (T1c-3; N0-3; M0). All patients were pathohistologically confirmed as HR+\u002FHER2- breast cancer. According to the breast cancer diagnosis and treatment guidelines and specifications of the Chinese Anti Cancer Association (2021 version), Luminal B is divided into Luminal B (HER2 negative) and Luminal B (HER2 positive). Luminal B (HER2 negative) is ER\u002FPR positive, HER2 negative and Ki-67 proliferation index is high or PR low expression. Luminal type B (HER2 positive) is ER\u002FPR positive, HER2 positive (protein overexpression or gene amplification), and Ki-67 in any state. Therefore, HR+\u002FHER2- breast cancer is a Luminal type breast cancer patient excluding HER2+.\n\n   Pathological examination of PD-L1 expression:\n\n   The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected the PD-L1 antibody site as 22C3.\n4. The functional level of major organs must meet the following requirements (no blood transfusion within 2 weeks before screening, no use of...)\n\nUsing leukocyte and platelet boosting drugs:\n\n1. Blood routine: Absolute neutrophil count (ANC) greater than 1.5 × 109\u002FL; platelet count (PLT) greater than 75 × 109\u002FL; Hemoglobin (Hb) is greater than 90g\u002FL; Lymphocyte count ≥ 1.5 × 109\u002FL\n2. Blood biochemistry: Total bilirubin (TBIL) is less than 1.5 × ULN; Alanine aminotransferase ALT and aspartate levels are less than 1.5 × ULN; Alkaline phosphatase is less than 2.5 × ULN; Urea nitrogen\u002F Urea (BUN\u002FUREA) and creatinine (Cr) are less than 1.5 × ULN.\n3. Cardiac ultrasound: Left ventricular ejection fraction (LVEF) greater than 55%.\n4. 12 lead electrocardiogram: The Fridericia corrected QT interval (QTcF) is less than 470 milliseconds 5. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.\n\n6\\. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer.\n2. Inflammatory breast cancer.\n3. Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.\n4. Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.\n5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.\n6. Serious heart disease or discomfort, including but not limited to the following diseases:\n\n1\\) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).\n\n2\\) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).\n\n3\\) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and\u002For diastolic blood pressure greater than 180mmHg after drug treatment) 100mmHg). 7. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.\n\n8\\. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment \\[HBV-DNA test negative or\\<50IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA test negative\\]).\n\n9\\. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.\n\n10\\. Individuals with a known history of allergies to the components of this medication regimen.\n\n11\\. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication.\n\n12\\. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.",{"count":43,"type":21},[84],"This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+\u002FHER2- breast cancer with Toripalimab combined with neoadjuvant chemotherapy and sequential Toripalimab monoclonal antibody, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)",[27],[304,330,306,307],"Toripalimab",{"date":310,"type":35},{"date":333,"type":35},"2024-06-11",{"date":335,"type":21},"2029-06",{"name":316,"class":74},11,{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":22,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":124},"100582224","phase-2-serplulimab-combined-with-chemotherapy-for-early-stage-hrher2--breast-cancer-100582224","NCT06860529","Serplulimab Combined With Chemotherapy for Early-stage HR+\u002FHER2- Breast Cancer","3.1 Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible:\n\nAge: ≥18 years old.\n\nClinical-pathological confirmation:\n\ncT2-cT4 breast cancer, or cT1c with axillary lymph node metastasis.\n\nHistopathologically confirmed HR+\u002FHER2- invasive breast cancer:\n\nER and\u002For PR positive (IHC nuclear staining ≥1%).\n\nHER2-negative (IHC 0 or 1+ without FISH testing, or IHC 2+ with FISH-negative amplification).\n\nKi67 ≥20%.\n\nClinically measurable lesions:\n\nMeasurable lesions confirmed by ultrasound, mammography, or MRI (optional) within 1 month prior to randomization.\n\nAdequate organ and bone marrow function (within 1 month prior to chemotherapy):\n\nAbsolute neutrophil count (ANC) ≥2.0 × 10\\^9\u002FL.\n\nHemoglobin ≥90 g\u002FL.\n\nPlatelet count ≥100 × 10\\^9\u002FL.\n\nTotal bilirubin \\\u003C1.5 × ULN (upper limit of normal).\n\nCreatinine \\\u003C1.5 × ULN.\n\nAST\u002FALT \\\u003C1.5 × ULN.\n\nCardiac function: Left ventricular ejection fraction (LVEF) ≥55% by echocardiography.\n\nReproductive status: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization.\n\nECOG performance status: ≤1.\n\nInformed consent: Signed written informed consent.\n\n3.2 Exclusion Criteria\n\nPatients meeting any of the following criteria will be excluded:\n\nEvidence of metastatic breast cancer:\n\nChest\u002Fabdominal CT and bone scan required at any time from diagnosis to randomization to exclude metastasis.\n\nPET\u002FCT may substitute for other imaging modalities.\n\nPrior systemic therapy: Chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.\n\nSecond primary malignancy, except:\n\nAdequately treated non-melanoma skin cancer.\n\nPrior immunotherapy: Treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors.\n\nImmune-related conditions:\n\nDiagnosed immunodeficiency or active autoimmune disease.\n\nSevere cardiopulmonary disease: Uncontrolled or clinically significant.\n\nActive hepatitis: Hepatitis B or C with detectable viral load.\n\nTransplant history: Prior organ or bone marrow transplantation.\n\nPregnancy or lactation: Pregnant or breastfeeding women.\n\nOther contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.",{"count":345,"type":21},357,[84],"The neoadjuvant treatment options commonly used for HR+\u002FHER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.\n\nThe aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+\u002FHER2- breast cancer",[27],"2025-06-20",{"date":351,"type":35},"2025-06-23",{"date":353,"type":35},"2025-04-15",{"date":355,"type":21},"2030-03-31",{"name":233,"class":101},{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":365,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":124},"100593395","phase-2-hormonal-receptor-hr-positive-her2-negative-breast-cancer-patients-treated-with-preoperative-elacestrant-and-pulsar-radiotherapy-100593395","NCT07005882","Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy","Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Adaptive Radiotherapy: a Phase II Study (HELP Trial)","HELP","Inclusion Criteria:\n\n1. Histologically proven HR-positive, HER2-negative BC\n2. Clinical disease stage II-III\n3. Post-menopausal female patients or male patients\n4. Eligible for neoadjuvant treatment and subsequent surgery\n5. No contraindication to MRI\n6. Patient able to understand and follow instructions during the trial\n7. Patient able and willing to give written informed consent, signed and dated\n8. Patient aged at least 50 years old\n9. Patient with tumor accessible for biopsy and surgery\n10. Patient with adequate bone marrow function at Screening, confirmed at Baseline, including:\n\n    1. ANC ≥ 1.5 × 109\u002FL; patients with documented benign cyclical neutropenia are eligible if white blood cell count is ≥ 1.5 × 109\u002FL, with ANC ≥ 1.0 × 109\u002FL, leukocytes ≥ 4.0 × 109\u002FL, and lymphocytes ≥ 0.6 × 109\u002FL;\n    2. platelets ≥ 100 × 109\u002FL;\n    3. hemoglobin ≥ 9 g\u002FdL (may have been transfused);\n11. International Normalized Ratio (INR) \\\u003C 1.5×Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR \\\u003C 3\n12. Patient with adequate hepatic function at Screening, confirmed at Baseline, defined by:\n\n    a. total bilirubin level ≤1.5×ULN; patients with documented Gilbert disease are allowed if total bilirubin ≤3×ULN; aspartate aminotransferase (AST) level ≤2.5×ULN, and alanine aminotransferase (ALT) level ≤2.5×ULN,\n13. Patient with adequate renal function at Screening, confirmed at Baseline, defined by eGFR ≥ 30 mL\u002Fmin using 2021 CKD-EPI creatinine equation\n14. Patient with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n15. Life expectancy of at least 12 months according to the Investigator's judgement\n\nExclusion Criteria:\n\n* 1\\. Patients with stage IV disease 2. Patients with a history of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, based on the Investigator's judgement, provides a reasonable suspicion of a disease or condition that contraindicates the use of RT and\u002For Elacestrant or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications.\n\n  3\\. Patients with any significant co-morbidity which, according to the Investigator's judgement, makes patient compliance to trial conditions unlikely.\n\n  4\\. Patients with previous malignant disease (other than the tumor disease for this trial) within the last five (5) years (except adequately treated non-melanoma skin cancers and carcinoma in situ of skin, bladder, cervix, colon\u002Frectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least two (2) years prior to Screening, and the patient is deemed to have been cured with no additional therapy required or anticipated to be required.\n\n  5\\. Patients with a history of uncontrolled intercurrent illness. 6. Patients with a known prior hypersensitivity or contraindications to Elacestrant or any component in its formulations.\n\n  7\\. Patients with severe acute or chronic medical conditions, including:\n  1. Immune colitis\n  2. Inflammatory bowel disease\n  3. History of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline\n  4. Immune pneumonitis\n  5. Pulmonary fibrosis\n  6. Psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior\n  7. Laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this trial.\n\n     8\\. Patients with a history of small intestine resection surgery or other major gastrointestinal surgery.\n\n     9\\. Patients with an active infection requiring systemic therapy with antibiotics (at both Screening and Baseline).\n\n     10\\. Patients with a known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome or multi-drug-resistant gram-negative bacteria.\n\n     11\\. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody Screening test positive).\n\n     12\\. Patients with increased anesthesiological risk (e.g. known or predicted difficult airway) if general anesthetic is required.\n\n     13\\. Premenopausal patients (defined as any woman who is not surgically sterile with a hysterectomy and\u002For bilateral oophorectomy or \\>12 months of amenorrhea and at least 50 years of age) 14. Patients aged less than 50 years old. 15. Patients with a known history of drug\u002Fsubstance abuse. 16. Patients participating in any other clinical trial within 30 days before Screening.\n\n     17\\. Patients receiving any other treatment that, in the opinion of the Investigator, might interfere with the trial.\n\n     18\\. Concomitant use of strong or moderate CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered.\n\n     19\\. Concomitant use of strong or moderate CYP3A4 inducers should be avoided and an alternative concomitant medicinal product with no or minimal potential to induce CYP3A4 should be considered.\n\n     20\\. Patients with a current drug or substance abuse. 21. Patients receiving chronic concurrent therapy within two (2) weeks before the trial treatment or expected therapy during the trial treatment period with:\n\n  \u003C!-- -->\n\n  1. Corticosteroids (except systemic corticosteroids up to 10 mg prednisolone or equivalent daily dose).\n  2. Immunosuppressive agents.\n  3. Antibiotics.\n  4. Any other anticancer therapy or concurrent anticancer treatment. 22. Patients who are unable to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.\n\n     23\\. Patients who are unlikely to comply with the Protocol requirements, instructions and trial-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial.\n\n     24\\. Patients with legal incapacity or limited legal capacity. 25. Patients with any condition which results in an undue risk for the patient during the trial participation according to the Investigator.","50 Years",{"count":5,"type":21},[84],"This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR.\n\nThe study will enroll 21 postmenopausal patients with early HR+ HER2- node positive BC, clinically staged II-III. Patients will receive Elacestrant 345 mg orally once daily for 24 weeks and PULSAR on the MRI-based breast gross tumor volume (GTVt), consisting of 10 Gy \"pulse\" every 4 weeks for a maximum of 5 or less in case of radiologic complete response.\n\nSurgery will be planned 24 weeks after Elacestrant initiation and at least 2 weeks from the last pulse and will be performed as per recommended clinical practice. Patients will then receive adjuvant systemic therapy as per standard of care and postoperative RT to the locoregional lymph nodes in case of nodal residual disease, if indicated.",[370,371,27,372],"Breast Cancer Patients","Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Radiation Therapy","2025-06-03",{"date":375,"type":35},"2025-06-05",{"date":377,"type":21},"2025-09-01",{"date":379,"type":21},"2028-03-01",{"name":381,"class":74},"Azienda Ospedaliero-Universitaria Careggi",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":386,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":157,"enrollmentInfo":387,"targetDuration":4,"studyType":22,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":290},"100591243","phase-3-neoadjuvant-chemotherapy-in-combination-with-toripalimab-for-hrher2--breast-cancer--a-randomized-open-label-parallel-controlled-multi-center-phase-iii-study-neotorch-breast04-100591243","NCT06977893","Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+\u002FHER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)",{"count":388,"type":21},194,[24],"Our center plans to conduct a randomized, open-label, parallel-controlled, multi-center phase III study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Toripalimab for HR+\u002FHER2- breast cancer. The aim is to further explore the treatment strategy of chemotherapy with immunotherapy for patients with HR+\u002FHER2- breast cancer, provide more treatment options for breast cancer patients, and offer a potential theoretical basis for the precision treatment of breast cancer.The primary study objective is to evaluate the pathologic complete response（PCR）and RCB0-1 ratio of neodjuvant treatment of HR+\u002FHER2- breast cancer.",[27],[304,330,306,249,307],"2025-05-12",{"date":395,"type":35},"2025-05-18",{"date":397,"type":35},"2025-03-24",{"date":399,"type":21},"2030-03-23",{"name":316,"class":74},{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":411,"phases":4,"briefSummary":412,"conditions":413,"keywords":449,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":462,"locationsCount":464},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":410,"type":21},3500,"OBSERVATIONAL","PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[414,415,416,417,87,88,418,116,419,420,421,422,423,424,27,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,61,91,448],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Carcinoma","Breast Neoplasms, Male","Breast Cancer With Metastatic Bone Disease","Breast Cancers","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive HER-2 Negative Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","CDK4\u002F6 Inhibitors",[450,451,446,447,61,452,453,454],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","Metastatic Breast Cancer","2025-01-28",{"date":457,"type":35},"2025-02-03",{"date":459,"type":35},"2023-05-01",{"date":461,"type":21},"2040-12-31",{"name":463,"class":74},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24,{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":472,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":479,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":4},"100565245","phase-2-neoadjuvant-chemotherapy--pd-1-inhibitordifferent-radiotherapy-fractionations-for-hrher2--breast-cancer-100565245","NCT06639672","Neoadjuvant Chemotherapy + PD-1 Inhibitor+Different Radiotherapy Fractionations for HR+\u002FHER2- Breast Cancer","Neoadjuvant Chemotherapy Combined With PD-1 Inhibitor and Different Radiotherapy Fractionations for HR+\u002FHER2- Breast Cancer: A Phase II Study","Inclusion Criteria:\n\n* 1\\. Histologically or cytologically confirmed HR+\u002FHER2- breast cancer\n* 2\\. cT1c-2N1-2M0 or cT3N0-2M0（AJCC 7th）\n* 3\\. ECOG performance status of 0-1;\n* 4\\. Adequate bone marrow function, defined as: Hb ≥ 9.0 g\u002FdL (90 g\u002FL); ANC ≥ 1,500\u002FmcL (1.5 × 10\\^9\u002FL); PLT ≥ 100,000\u002FmcL (100 × 10\\^9\u002FL) and no blood transfusion within 3 weeks or growth factor (G-CSF, EPO) therapy within 2 weeks prior to dosing;\n* 5\\. Adequate liver function, defined as: TBIL ≤ 1.5× upper limit of normal (ULN); If no liver metastases, AST and ALT ≤ 2.5× ULN; if liver metastases are present, AST or ALT ≤ 3.0× ULN; ALP ≤ 1.5× ULN; if liver metastases ≤ 2× ULN; Serum albumin ≥ 30g\u002FL;\n* 6\\. Adequate coagulation function: INR or PT, APTT ≤ 1.5× ULN. Participants on anticoagulant therapy should have these laboratory indices closely monitored;\n* 7\\. Adequate renal function, defined as creatinine ≤ 1.5× ULN or Ccr ≥ 50 mL\u002Fmin calculated using the Cockcroft-Gault formula corrected for body surface area;\n* 8\\. Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram (ECHO);\n* 9\\. No severe organic heart disease or arrhythmias;\n* 10\\. Women of childbearing potential (aged 15-49 years) must have a negative pregnancy test within 7 days before starting treatment. Both male and female participants of reproductive potential must agree to use effective contraceptive measures during the study period and for 3 months after discontinuation of treatment;\n* 11\\. Voluntary signed informed consent by the study participant.\n\nExclusion Criteria:\n\n* 1\\. Patients with a history of mental illness or those diagnosed with mental disorders at the time of enrollment in the clinical trial.\n* 2\\. Patients with communication barriers due to confusion, aphasia, intellectual disability, or other reasons that prevent them from responding normally.\n* 3\\. Poorly controlled tumor-related pain.\n* 4\\. Patients participating in other clinical studies simultaneously.\n* 5\\. Patients with active or past autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* 6\\. A history of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest CT scans at screening.\n* 7\\. Active pulmonary tuberculosis.\n* 8\\. Severe cardiovascular diseases occurring within 3 months prior to the start of study treatment (e.g., NYHA class II or higher heart disease, myocardial infarction, or cerebrovascular accident), unstable arrhythmias, or unstable angina.\n* 9\\. Patients who underwent significant surgical procedures, other than diagnostic surgeries, within 4 weeks prior to the start of the study treatment, or are expected to require significant surgical procedures during the study period.\n* 10\\. Patients who had malignant tumors other than breast cancer within the last 5 years, except for malignancies in the study that have negligible risks of metastasis or death , such as adequately treated cervical carcinoma in situ, non-melanoma skin cancer, ductal carcinoma in situ, or stage I uterine cancer.\n* 11\\. Patients who experienced severe infections within 4 weeks prior to the start of the study treatment, including but not limited to those requiring hospitalization due to infections, bacteremia, severe pneumonia, or any active infection that may impact patient safety.\n* 12\\. Patients who have previously received allogeneic stem cell or solid organ transplants.\n* 13\\. Any other diseases, metabolic dysfunctions, physical examination abnormalities, or clinical laboratory abnormalities that contraindicate the use of the study drug, may affect the interpretation of results, or pose a high risk of treatment complications for the patient.","65 Years",{"count":474,"type":21},60,[84],"For the hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2-negative (HER2-) subtype of breast cancer, although surgical, radiotherapy, and endocrine treatments have shown better survival, this subtype has a relatively poor response to neoadjuvant chemotherapy and immunotherapy, with an approximately pCR of 20%. The low immunogenicity result in suboptimal pCR and objective response rates for this group. Therefore, there is an urgent need to explore new, highly effective, and low-toxicity treatment strategies to further improve the efficacy of HR+\u002FHER2- breast cancer. Radiotherapy has systemic immune regulatory effects by promoting the release of antigens from tumor cells, enhancing T-cell infiltration, and directly killing tumor cells. Therefore, this study aims to investigate the efficacy and safety of chemotherapy combined with PD-1 inhibitor and different radiotherapy fractionations in the neoadjuvant treatment of HR+\u002FHER2- breast cancer.",[478],"HR+HER2- Breast Cancer",[480,481,249,248],"HR+\u002FHER2- breast cancer","Neoadjuvant chemotherapy","2024-10-11",{"date":484,"type":35},"2024-10-15",{"date":486,"type":21},"2024-11-01",{"date":488,"type":21},"2031-05-01",{"name":490,"class":74},"Lei Liu",{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":124},"100384157","phase-1-a-study-of-bpi-1178-in-patients-with-advanced-solid-tumor-and-hrher2--breast-cancer-100384157","NCT04282031","A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+\u002FHER2- Breast Cancer","A Phase 1\u002F2a Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of BPI-1178 Alone in Advanced Solid Tumor and of BPI-1178 in Combination With Endocrine Therapy in Advanced HR+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n1. Have given written informed consent prior to any study specific procedures.\n2. Male or female, aged ≥18 years.\n3. Subjects with advanced solid tumors:\n\n   * Phase 1: Histologically or cytologically confirmed, locally advanced (not amenable to curative treatment of surgical resection or radiation therapy), recurrent, or metastatic solid tumors that were refractory to standard therapy or for which no standard-of-care therapy.\n   * Phase 2a Cohort A: HR+\u002FHER2- locally advanced, recurrent, or metastatic breast cancer with disease progression after first-line endocrine therapy (not fulvestrant) or intolerant of it, histologically confirmed by the primary and\u002For metastatic lesions, not amenable to chemotherapy or curative treatment of surgical resection or radiation therapy; if the pathology of the primary and metastatic lesions are inconsistent, diagnosis should be based on metastatic lesions' pathology.\n   * Phase 2a Cohort B: HR+\u002FHER2- locally advanced, recurrent, or metastatic breast cancer with no prior systemic therapy in this disease setting or relapse more than 1 years from completion of adjuvant endocrine therapy, histologically confirmed by the primary and\u002For metastatic lesions, not amenable to chemotherapy or curative treatment of surgical resection or radiation therapy; if the pathology of the primary and metastatic lesions are inconsistent, diagnosis should be based on metastatic lesions' pathology.\n   * Female patients with breast cancer at Phase IIa must also meet the following criteria:\n\n     (1) Postmenopausal patients must meet at least one of the following criteria:\n     1. Age ≥ 60 years old;\n     2. Patients \\\u003C 60 years of age who have menstruation ceased for at least 12 consecutive months and have not received chemotherapy, tamoxifen, toremifene or ovarian function inhibitors, and have blood estrogen and FSH levels within the reference range for postmenopausal women;\n     3. Previous bilateral ovariectomy;\n     4. Patients \\\u003C 60 years of age who are being treated with tamoxifen or toremifene with blood estrogen and FSH levels within the reference range for postmenopausal women.\n\n     (2) Premenopausal\u002Fperimenopausal patients must meet the following criteria: Premenopausal\u002Fperimenopausal patients requiring ovarian function suppression must start treatment at least 4 weeks prior to enrollment and the treatment should be maintained during the trial.\n4. At least 1 measurable lesion based on the RECIST v1.1 criteria.\n5. Life expectancy≥ 12 weeks.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)≤1.\n7. Adequate bone marrow and organ function, defined as following:\n\n   1. absolute neutrophil count≥1.5×10\\^9\u002FL, platelets≥100×10\\^9\u002FL, hemoglobin≥100 g\u002FL;\n   2. total bilirubin≤1.5×ULN(≤3×ULN for Gilbert syndrome), alanine aminotransferase and aspartate aminotransferase≤3×ULN;\n   3. serum creatinine≤1.5×ULN or a creatinine clearance calculated by Cockcroft-Gault formula≥50 mL\u002Fmin; urinary protein measured by semi-quantitative method\\\u003C2+; if urinary protein measured by semi-quantitative method at baseline ≥2+, 24-h urinary protein\\\u003C1g;\n   4. activated partial thromboplastin time and international normalized ratio≤1.5×ULN;\n   5. LVEF≥50%;\n   6. Corrected QT interval (QTcF)\\\u003C450ms for men and \\\u003C470ms for women at resting.\n8. Female subjects should take effective contraceptive methods during the study and for 60 days after the last dose of BPI-1178, and must have a negative pregnancy test prior to dosing if of child-bearing potential, or must have evidence of non-child-bearing potential; male subjects should take effective contraceptive methods during the study and for 120 days after the last dose of BPI-1178.\n9. All subjects must have enough mental behavior ability, understand the nature and significance of the study, as well as the risks associated with the study.\n\nExclusion Criteria:\n\n1. Currently receiving or have received any CDK4\u002F6 inhibitors.\n2. Have had allergies or history of severe allergies.\n3. Have participated in any clinical trials within 4 weeks prior to the dosing of BPI-1178.\n4. Have received anti-tumor therapy (including chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, etc.; have received radiotherapy within 2 weeks before taking the investigational product) within 4 weeks before starting to take the investigational product \\\u003Cexcept for premenopausal\u002Fperimenopausal patients with Gonadotropin-releasing hormone analogues \\[GnRHa\\] therapy allowed in Phase IIa study\\>.\n5. Other malignancies present or previously present at the time of enrollment or still under treatment at the time of enrollment (only applicable to Phase IIa study)\n6. Any toxicity related to previous treatment before enrollment defined by CTCAE (v5.0) Grade≥2 (except hair loss).\n7. Presence of third interstitial fluid that cannot be controlled by drainage or other methods (such as large amounts of pleural fluid and ascites).\n8. Requiring long-term treatment of steroid.\n9. Having uncorrectable hypokalemia and hypomagnesemia at enrollment.\n10. Meet any of the following criteria: Various clinically significant heart rhythm and conduction abnormalities, such as atrial fibrillation, complete left bundle branch block, Level III conduction block, Level II conduction block, and PR interval \\> 250 msec; Various factors that might increase risks of QT increased or arrhythmia events, e.g., symptomatic cardiac failure - New York Heart Association (NYHA) class 2-4, long QT syndrome congenital, Brugada syndrome, previous histories of QT increased (\\> 470 ms for males, \\> 480 ms for females) or TdP attack, first degree relative of the family with long QT syndrome or sudden death before 40 years' old with unexplained cause, and concomitant medication which may prolong QT interval; Suffering from following diseases within 6 months prior to administration of investigational product, including unstable angina pectoris, myocardial infarction, coronary heart disease, cerebrovascular accident or pulmonary embolism, or accepting cardiac revascularization.\n11. Known active infection, such as hepatitis B (HBV DNA ≥ 200 IU\u002FmL), hepatitis C, human immunodeficiency virus (HIV) infection.\n12. Have a history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n13. Based on the judgement of investigators, there might be multiple factors which could impact taking and absorption of BPI-1178, including gastrointestinal factors (e.g., obviously uncontrollable inflammatory gastrointestinal disorder, abdominal colostomy within 6 months or previous history of gastrointestinal perforation, extensive resection of small intestine and requirement of tube feeding or water\u002F nutritional supplement by parenteral route, inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)\n14. Have spinal cord compression, metastases of the meninges, or brain metastases with obvious symptoms. The following cases of brain metastases without symptoms can be enrolled: brain metastases without obvious symptoms diagnosed at screening visit, steroids and\u002For local treatment not required judged by investigator; brain metastases without obvious symptoms after local treatment (such as radiotherapy), and steroids and\u002For antiepileptic therapy has stopped for at least 7 days before the first dosing of BPI-1178.\n15. In the judgment of the investigator, have a concomitant disease (such as severe hypertension, diabetes, thyroid disease, severe infection, portal hypertension, cirrhosis, etc.) that would endanger the subjects' safety or affect the completion of the study.\n16. Have had major surgery (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures within 4 weeks prior to the dosing of BPI-1178.\n17. Pregnant or lactating women, or fertile women with pregnancy test positive at baseline.\n18. Any factors that may endanger subject's safety and may affect subject's compliance with the study.\n19. Drug abuse, alcoholic addiction, medical and mental illness and social barriers judged by investigator, which may interfere the subjects' participation in the study or affect the evaluation of study endpoints . Any factor that investigator believes may make the subjects not suitable to receive BPI-1178. Subjects are unwilling or unable to comply with the requirements of the study protocol.",{"count":499,"type":21},224,[136,84],"BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4（CDK4）and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of oral BPI-1178 in patients with advanced solid tumors. The Phase IIa trial is designed to investigate the anti-tumor activity and safety of BPI-1178 in combination with endocrine therapy in patients with HR+\u002FHER2-advanced breast cancer and to determine the dosing regimen for combination with endocrine therapy in a later confirmatory study.",[271,27],"2024-08-05",{"date":505,"type":35},"2024-08-07",{"date":507,"type":35},"2020-06-15",{"date":509,"type":21},"2025-06-30",{"name":511,"class":42},"Beta Pharma (Suzhou) Co., Ltd.",{"id":513,"slug":514,"hasResults":11,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":22,"phases":521,"briefSummary":522,"conditions":523,"keywords":524,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":4},"100552249","phase-2-to-evaluate-the-efficacy-of-adebrelimab-combined-with-chemotherapy-after-hifu-induction-neoadjuvant-therapy-hrher2--breast-cancer-100552249","NCT06470633","To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+\u002FHER2- Breast Cancer","To Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy Neoadjuvant Therapy in Early or Local Advanced Breast Cancer After Induction Treatment of High-intensity Focused Ultrasound and Adebrelimab","Inclusion Criteria:\n\n1. Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment;\n2. Histopathologically confirmed breast cancer patients who with hormone receptor- positive, which defined as estrogen receptor (ER) ≥ 1%, and\u002F or progesterone receptor (PR) ≥ 1%, and HER-2 (0 or +), or ++,but FISH is no amplification;\n3. Tumor size ≥ 3cm, and histological grade is 3 (poorly differentiated);\n4. Regardless of lymph node status, but without distant metastasis;\n5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;\n6. ECOG PS score: 0 - 1;\n7. New York Heart Association (NYHA) functional class I;\n8. Electrocardiogram without myocardial ischemia, echocardiography LVEF \\> 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;\n9. Normal major organ function, Meet the following criteria:\n\nWBC ≥ 4.0 × 10 9\u002FL,Neutrophil count (ANC) ≥ 1.5 × 10 9\u002FL; platelet ≥ 100 × 10 9\u002FL; hemoglobin ≥ 10 g\u002FdL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN; 9.The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up.\n\nExclusion Criteria:\n\n1. Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders;\n2. Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.;\n3. Known allergy to the active ingredients or other components of the study drug or surgical contraindications;\n4. In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years;\n5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;\n6. Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;\n7. Patients who are participating in other clinical trials within one month;\n8. Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 \\[Mobitz 2\\] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension;\n9. Any other conditions that in the opinion of the investigator would make the patient inappropriate for participation in this study.",{"count":520,"type":21},29,[84],"To explore the efficacy and safety of adebrelimab combined with chemotherapy (epirubicin + cyclophosphamide →docetaxel) neoadjuvant therapy early HR+\u002FHER2- breast cancer with high risk factors after the induction treatment of HIFU and adebrelimab.",[116,27],[525,526,249,527],"HR+\u002FHER2- early breast cancer","HIFU","Neoadjuvant therapy","2024-06-18",{"date":530,"type":35},"2024-06-24",{"date":532,"type":21},"2024-08-01",{"date":534,"type":21},"2026-12-31",{"name":536,"class":74},"The First Affiliated Hospital with Nanjing Medical University",{"id":538,"slug":539,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":157,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":124},"100550480","phase-3-apatinib-combined-with-cdk46i-in-first-line-treatment-for-hrher2--snf4-subtype-breast-cancer-100550480","NCT06447623","Apatinib Combined With cdk4\u002F6i in First-line Treatment for HR+\u002FHER2- SNF4 Subtype Breast Cancer","Study of Efficacy of Apatinib Combined With cdk4\u002F6i in First-line Treatment for HR+\u002FHER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Patients need to meet all of the following conditions\n\n  * Patients must be ≥18 and ≤ 75 years of age;\n  * Pathologically confirmed breast cancer is HR+\u002FHER2- breast cancer (IHC ER \\>10%, or\u002Fand PR\\>10%, HER 0 OR +, if HER2++, FISH negative);\n  * SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\\&E sections;\n  * Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4\u002F6 inhibitors in the past, or one year after adjuvant CDK4\u002F6 inhibitor therapy has ended);\n  * No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;\n  * Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1;\n  * The functions of the main organs are basically normal, and the following conditions are met:\n\n    1. Blood routine examination standards should meet: HB≥90g\u002FL (no blood transfusion within 14 days); ANC≥1.5×109\u002FL; PLT≥75×109\u002FL;\n    2. Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance \\> 50ml\u002Fmin (Cockcroft-Gault formula);\n  * ECOG performance status 0 or 1; The expected survival is more than 3 months;\n  * Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;\n  * Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following conditions were excluded from the study\n\n  * Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).\n  * A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;\n  * Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+\u002FHER2- breast cancer within 4 weeks before the first administration of drugs used in this study.\n  * Pregnant or lactating patients;\n  * Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;\n  * Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient\\'s participation in the study;\n  * Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;\n  * The investigator does not consider the patient suitable for participation in any other circumstances of the study.",{"count":545,"type":21},184,[24],"This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+\u002F HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.",[280,27],[480,280],"2024-06-03",{"date":552,"type":35},"2024-06-07",{"date":554,"type":35},"2024-02-01",{"date":556,"type":21},"2029-02-01",{"name":558,"class":74},"Fudan University",{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":52,"minAge":18,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":22,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":4},"100547168","phase-2-ql1706-plus-chemotherapy-as-neoadjuvant-therapy-in-early-high-risk-erher2--breast-cancer-100547168","NCT06404463","QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+\u002FHER2- Breast Cancer","A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk ER+\u002FHER2- Early-Stage Breast Cancer (QUEEN-Neo)","QUEEN-Neo","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO\u002FCAP guidelines, histopathologically confirmed ER+\u002FHER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2;\n3. According to RECIST 1.1, there is at least one measurable lesion;\n4. ECOG score: 0\\~1;\n5. Tumor tissue specimens that can be used for biomarker detection;\n6. The function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication):\n\n(1) Absolute neutrophil count ≥1.5×109\u002FL; (2) Platelets ≥100×109\u002FL; (3) Hemoglobin ≥90 g\u002FL; (4) Serum albumin ≥30 g\u002FL; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).\n\nExclusion Criteria:\n\n1. The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);\n2. Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10 mg\u002Fday prednisone or other effective hormones), and are still using it within 2 weeks before enrollment;\n3. Severe allergic reactions to other monoclonal antibodies;\n4. Known history or evidence of interstitial lung disease or active non-infectious pneumonia;\n5. Those with known central nervous system metastasis;\n6. Suffered from other malignant tumors in the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical cancer in situ);\n7. Suffering from high blood pressure that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); the above parameters are allowed to be achieved through the use of antihypertensive treatment; there has been a hypertensive crisis or high blood pressure in the past Hypertensive encephalopathy;\n8. Have cardiac clinical symptoms or diseases that cannot be well controlled, such as (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc\\>450ms (male); QTc\\>470ms (female);\n9. Those who are receiving thrombolysis or anticoagulation therapy are allowed to use low-dose aspirin and low-molecular-weight heparin prophylactically;\n10. Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive during the baseline period, it can be re-examined. If it is still positive after the reexamination, a gastroscopy is required;\n11. The tumor invades important blood vessels, or the researcher determines based on imaging that there is a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding;\n12. Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage;\n13. Arterial\u002Fvenous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n14. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia patients, coagulation disorders, etc.);\n15. Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment;\n16. Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount \\>1.0 g;\n17. Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count \\>15×109\u002FL;\n18. Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU\u002Fml, or hepatitis C virus antibody positive;\n19. Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period;\n20. In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient's safety.","70 Years",{"count":569,"type":21},76,[84],"This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC\u002FEC in a neoadjuvant setting, in high-risk, ER+\u002FHER2- early breast cancer.",[192,573,478],"Neoadjuvant Therapy","2024-05-05",{"date":576,"type":35},"2024-05-08",{"date":578,"type":21},"2024-05-06",{"date":580,"type":21},"2030-11-06",{"name":558,"class":74}]