[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-breast-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,60,89,117,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100595203","phase-1-a-study-with-nkt5097-for-adults-with-advancedmetastatic-solid-tumors-100595203",false,"NCT07029399","A Study With NKT5097 for Adults With Advanced\u002FMetastatic Solid Tumors","A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2\u002FCDK4 Dual Degrader NKT5097 in Adults With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n* Able to provide written informed consent\n* Advanced unresectable or metastatic solid tumor (Part 1, 2 \\& 3 only)\n* Advanced unresectable or metastatic HR+\u002FHER2- breast cancer (Part 4 \\& 5 only)\n* Refractory to or unable to tolerate existing therapies (Part 1, 2 \\& 4 only)\n* Measurable or evaluable disease (Part 1, 2, \\& 4 only).\n* Measurable disease (Part 3 \\& 5 only)\n* Eighteen years of age or older\n* ECOG status of 0 or 1\n* Adequate organ function\n* Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol\n* Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose\n* Able to swallow oral meds\n* Willing to provide tumor tissue\n\nExclusion Criteria:\n\n* Advanced solid tumor that is a candidate for curative treatment\n* History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission\n* Not recovered from the effects of prior anticancer therapy\n* Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months\n* Known active CNS metastases and\u002For carcinomatous meningitis\n* Active interstitial lung disease requiring treatment\n* History of uveitis, retinopathy, or other clinically significant retinal disease\n* Major surgery within 30 days of administration of first dose\n* Active uncontrolled infectious disease\n* Significant liver disease (Child Pugh class B or C)\n* Should not have received any prior selective investigational inhibitors or degraders (Part 5 only)","ALL","18 Years",{"count":19,"type":20},361,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced\u002Fmetastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include:\n\n* What is the recommended dose for expansion and\u002For Phase 2, for both monotherapy and in combination with ET\n* What medical issues\u002Fsymptoms do participants experience when taking NKT5097 as monotherapy as well as in combination with ET",[26,27,28,29],"HR+ Breast Cancer","Triple Negative Breast Cancer (TNBC)","CCNE1 Amplified Advanced Solid Tumors","HR+ HER2- Breast Cancer",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46],"CCNE1","cyclin E1","triple negative breast cancer","TNBC","estrogen receptor positive","HER2-","breast cancer","post CDK4\u002F6i","HER2 expression","Fulvestrant","Letrozole","endocrine therapy","refractory","endocrine resistant","endocrine sensitivity","metastatic","RECRUITING","2026-06-25",{"date":50,"type":51},"2026-06-26","ACTUAL",{"date":53,"type":51},"2025-03-25",{"date":55,"type":20},"2027-12-31",{"name":57,"class":58},"NiKang Therapeutics, Inc.","INDUSTRY",18,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":78,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":86,"locationsCount":4},"100616567","phase-2-shr-a1811-plus-pertuzumab-as-neoadjuvant-therapy-for-early-or-locally-advanced-hr-positive-her2-positive-breast-cancer-a-prospective-open-label-phase-ii-study-100616567","NCT07307287","SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study","Inclusion Criteria:\n\n1. Female, aged 18-70 years at the time of informed consent.\n2. Histologically confirmed invasive breast cancer, with no prior systemic anti-cancer therapy.\n3. Pathologically documented HR-positive (ER ≥ 1% and\u002For PR ≥ 1%) and HER2-positive disease, per the 2018 ASCO-CAP guidelines: IHC 3+ or IHC 2+ with ISH ratio ≥ 2.0.\n4. Clinical stage II-III (cT2-cT4 or cN+, cM0) per the 8th edition of the AJCC Cancer Staging Manual.\n5. At least one measurable lesion per RECIST v1.1 criteria.\n6. ECOG performance status 0-1.\n7. Estimated life expectancy of ≥ 12 months.\n8. Adequate organ function within 14 days prior to the first dose (without transfusion or growth factor support):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelets ≥ 100 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL\n   2. Albumin ≥ 3.0 g\u002FdL; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT)\u002Faspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (per Cockcroft-Gault formula)\n   3. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n   4. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography\n   5. Fridericia-corrected QT interval (QTcF) ≤ 470 ms\n9. Premenopausal women with reproductive potential must have a negative serum β-human chorionic gonadotropin (β-hCG) test within 7 days before treatment, use effective barrier contraception throughout the study period and for 6 months after the last dose, and not be breastfeeding.\n10. Provision of signed written informed consent; willingness to comply with all study visits and procedures.\n\nExclusion Criteria:\n\n1. Breast cancer not confirmed by histopathology.\n2. Bilateral, inflammatory, or occult breast cancer.\n3. Any prior anti-cancer therapy (chemotherapy, radiotherapy, targeted, endocrine, etc.); radical radiotherapy ≤ 4 weeks or palliative radiotherapy ≤ 2 weeks before first dose.\n4. Concomitant anti-cancer therapy of any kind.\n5. Other malignancies within 5 years (except cured basal-cell skin cancer or cervical carcinoma in situ).\n6. Participation in another drug trial ≤ 4 weeks before enrolment.\n7. Systemic immunosuppressive therapy (e.g., \\> 10 mg\u002Fday prednisone equivalent) ≤ 2 weeks before first dose (nasal\u002Finhaled corticosteroids allowed).\n8. Live or attenuated vaccines ≤ 4 weeks before first dose.\n9. Major non-breast surgery ≤ 4 weeks before first dose or not fully recovered.\n10. Active autoimmune disease or history of recurrent autoimmunity (e.g., autoimmune hepatitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyper\u002Fhypothyroidism except stable hormone replacement). Controlled vitiligo, psoriasis, alopecia, insulin-dependent type 1 diabetes, or childhood asthma in complete remission allowed. Asthma requiring bronchodilators excluded.\n11. Immunodeficiency (HIV positive, congenital\u002Fsecondary), prior organ transplant.\n12. Uncontrolled or significant cardiovascular\u002Fcerebrovascular disease, including within 6 months: NYHA III\u002FIV heart failure, MI, stroke (except lacunar), pulmonary embolism, unstable angina, significant arrhythmia; cardiomyopathies; QTc \\> 470 ms (Fridericia, female), 2nd\u002F3rd degree AV block, atrial fibrillation ≥ EHRA 2b, uncontrolled hypertension.\n13. Interstitial lung disease or any moderate-severe pulmonary disorder that may interfere with drug-related lung toxicity assessment: idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans, pulmonary embolism, severe asthma\u002FCOPD, restrictive\u002Fobstructive defects, autoimmune\u002Fconnective-tissue lung involvement, prior pneumonectomy.\n14. Active hepatitis B (HBsAg+ and HBV DNA ≥ 500 IU\u002FmL), hepatitis C (anti-HCV+ and HCV RNA \\> ULN), cirrhosis, or severe infection requiring antibiotics\u002Fantivirals\u002Fantifungals.\n15. Hereditary\u002Facquired bleeding or thrombotic diatheses (e.g., hemophilia, coagulopathy).\n16. Known hypersensitivity to study drugs or excipients.\n17. Pregnant or lactating women; women of child-bearing potential with positive baseline pregnancy test or unwilling to use effective contraception throughout the study.\n18. Any severe concomitant condition jeopardizing patient safety or compliance (e.g., uncontrolled hypertension, diabetes, active infection) or significant neurologic\u002Fpsychiatric disorder (epilepsy, dementia) that, in the investigator's opinion, renders","FEMALE","75 Years",{"count":69,"type":20},30,[71],"PHASE2","Breast cancer is the most common malignancy in women, with approximately 20% classified as HER2-positive. Anti-HER2 blockade (trastuzumab plus pertuzumab) combined with chemotherapy constitutes the standard neoadjuvant regimen; however, the pathological complete response (pCR) rate in the HR-positive subgroup remains only 35-40%, and platinum-containing schedules are associated with significant hematologic toxicity. Antibody-drug conjugates (ADCs) integrate targeted delivery with potent cytotoxic payloads. SHR-A1811 (ruikang-trastuzumab), a domestically developed ADC by Hengrui Pharmaceutical, is conjugated with a topoisomerase I inhibitor (mean drug-to-antibody ratio \\[DAR\\] ≈ 6). Preclinical data demonstrate that SHR-A1811 exhibits superior efficacy to trastuzumab emtansine (T-DM1) in both trastuzumab-sensitive and resistant HER2-expressing tumor models, with a manageable safety profile.\n\nThis prospective, open-label, phase II trial will enroll patients with early-stage\u002Flocally advanced HR-positive\u002FHER2-positive breast cancer, who will receive neoadjuvant SHR-A1811 plus pertuzumab. At baseline, BluePrint gene profiling will be performed to stratify participants into luminal and non-luminal subtypes: patients with luminal subtype who achieve stable disease (SD) after 4 cycles will switch to a regimen of trastuzumab, pyrotinib, dalpiciclib, and an aromatase inhibitor for an additional 4 cycles; all other patients will continue ADC-based dual-target therapy for 2-4 further cycles, followed by surgical resection. Circulating tumor DNA (ctDNA) dynamics will be dynamically monitored at baseline, after 4 cycles of treatment, and preoperatively to evaluate early treatment sensitivity.\n\nThe primary endpoint is the pCR rate. Secondary endpoints include event-free survival (EFS), objective response rate (ORR), and safety profiles. Exploratory analyses will investigate the correlation between molecular subtypes and treatment responses, aiming to establish a chemotherapy-free, precision neoadjuvant strategy for HR-positive\u002FHER2-positive breast cancer.",[74,75,26,76,77],"SHR-A1811","HER2-Postive Breast Cancer","Early Breast Cancer","Locally Advanced Breast Cancer",[74,75,26,76],"NOT_YET_RECRUITING","2025-12-14",{"date":82,"type":51},"2025-12-29",{"date":84,"type":20},"2025-12-20",{"date":55,"type":20},{"name":87,"class":88},"Tianjin Medical University Cancer Institute and Hospital","OTHER",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100576578","phase-3-study-assessing-the-efficacy-and-safety-of-cannabidiol-oral-solution-for-joint-pain-of-adjuvant-endocrine-therapy-in-patients-with-early-breast-cancer-100576578","NCT06787118","Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer","Randomized, Double-blind, Placebo-controlled, 2x2 Cross Over Study Assessing the Efficacy and Safety of cANnabidiol Oral Solution for Joint Pain of Adjuvant enDOcrine theRApy in Patients With Early Breast Cancer","PANDORA","Inclusion Criteria:\n\nGeneral inclusion criteria:\n\n1. Patient must understand, sign and date the written informed consent form (ICF) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedure as per protocol.\n2. Patient must be affiliated to a social security system or beneficiary of the same.\n3. Patient is ≥ 18 years-old at the time of study inclusion\n4. Patient has histologically confirmed invasive Stage I, II, III breast cancer.\n5. Patient has breast cancer that is positive for ER and\u002For PgR (nuclear staining of any intensity ≥ 10%)\n6. Patients should be taking a standard dose of one of the three approved AIs (i.e., anastrozole, exemestane, or letrozole) for at least 21 days, and not more than 36 months before trial registration; premenopausal patients are eligible if they are receiving AIs and ovarian function suppression (LHRH agonist).\n7. If indicated, patient has completed adjuvant and\u002For neoadjuvant chemotherapy according to the institutional guidelines, prior to randomization.\n8. If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines, prior to randomization.\n9. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n10. Patients should report an Interference pain score of ≥ 4 out of 10 on the Brief Pain Inventory (BPI, Appendix 2) within 7 days before registration.\n11. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n12. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative urine or serum pregnancy test (for β- hCG) within 14 days of randomization.\n13. Women of CBP, defined as all women physiologically capable of becoming pregnant, must be willing to use highly effective methods of contraception. It is recommended that sexually active males use a condom during intercourse and it is strongly advised that they do not father a child in this period (a condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid). In all patients, contraception must continue during the trial treatment and for 3 months after stopping it, due to AI treatment. For women, highly effective contraception methods include:\n\n    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;\n    2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of bilateral oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment;\n    3. Placement of an intrauterine device (IUD). Notes:\n\n       * Use of oral (estrogen and progesterone), transdermal, injected or implanted hormonal methods of contraception (as well as hormonal replacement therapy) is not allowed in this trial.\n       * Women are considered of CBP unless: they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks ago.\n\n    Specific inclusion criteria for CBD use:\n14. Patient has adequate bone marrow and organ function as defined by the following local laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n    2. Platelets ≥ 100 × 109\u002FL\n    3. Hemoglobin ≥ 9.0 g\u002FdL\n    4. Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin by a Cockcroft-Gault formula.\n    5. Alanine transaminase (ALT) ≤ 1.5 × Upper Limit Normal (ULN)\n    6. Aspartate transaminase (AST) ≤ 1.5 × ULN\n    7. Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin ≤ 1.5 × ULN in patients with well documented Gilbert's Syndrome\n    8. International normalized ratio (INR) ≤ 1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to randomization).\n    9. Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements (the local laboratory value should be documented within normal limits after the correction) before randomization:\n\n       * Sodium\n       * Potassium\n       * Phosphorus\n       * Magnesium\n       * Total Calcium\n15. Standard 12-lead ECG values defined as the mean of the triplicate ECGs as locally assessed:\n\n    1. QTcF interval (using Fridericia's correction) at screening \\\u003C 450 msec\n    2. Mean resting heart rate 50-90 bpm (determined from the ECG)\n\nExclusion Criteria:\n\nGeneral exclusion criteria:\n\n1. Patient with distant metastases of breast cancer beyond regional lymph nodes (M1 disease according to AJCC 8th edition).\n2. Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and\u002For surgery (i.e. patient has toxicities attributed to prior anti-neoplastic therapy NCI CTCAE version 5.0 grade ≥1 at day of randomization, excluding alopecia and amenorrhea)\n3. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to randomization\n4. Patient has previous history of bone fracture or surgery of the affected knees, hands or both within 6 months prior to enrolment or known rheumatologic diseases;\n5. Patient has received opioids analgesics, systemic NSAIDs, topical analgesics, oral, intra-articular or intramuscular corticosteroids for treatment of joint pain or joint stiffness within 28 days prior registration;\n6. Patient has active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n7. Patients with moderate (Child-Pugh B) hepatic impairment or severe (Child-Pugh C) hepatic impairment.\n8. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).\n9. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigators judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic anti-bacterial therapy, etc.) or limit life expectancy to ≤5 years.\n10. Participation in a prior interventional study and received trial treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.\n11. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breastfeed during the trial.\n12. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or under justice protection or under curatorship or unable of giving his consent\n\n    Specific exclusion criteria for CBD use:\n13. Patient with a known hypersensitivity to CBD or any of the excipients of CBD\n14. Previous serious adverse reaction to any cannabinoid product such as cannabinoid related psychosis, panic attack or delirium.\n15. Recreational or medicinal cannabis or synthetic cannabinoid based medications (including Sativex®) within 2 weeks before study entry\n16. Patient has previous or active psychological, psychiatric or central nervous system disorders, including epilepsy; schizophrenia or any other psychosis, severe borderline personality, patient with significant suicidal ideation.\n17. Patient takes drugs as clobazam, valproate, or levodopa;\n18. Patient has previous history of substance abuse or dependence to alcohol, opioids, amphetamines, benzodiazepines and other illicit stimulants.\n19. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n    1. History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to trial entry\n    2. Documented cardiomyopathy\n    3. Prior history of LVEF \\\u003C50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) which did not recover before study entry\n    4. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n       * Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia\n       * Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting trial treatment)\n       * Inability to determine the QTcF interval\n    5. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block)\n    6. Uncontrolled arterial hypertension with systolic blood pressure (SBP) \\> 160 mmHg",{"count":98,"type":20},130,[100],"PHASE3","Phase III, single-center, randomized, double-blind, placebo-controlled, 2x2 cross- over study, assessing the efficacy of CBD in patients with early HR+ BC, presenting aromatase inhibitor-related musculoskeletal pain",[103,104,105,26,106],"Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","AI-related Musculoskeletal Pain","2025-11-24",{"date":109,"type":51},"2025-12-02",{"date":111,"type":20},"2025-12",{"date":113,"type":20},"2027-05",{"name":115,"class":88},"Gustave Roussy, Cancer Campus, Grand Paris",1,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":67,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100599140","phase-2-sc-101-in-subjects-with-advanced-nectin4-amplified-cancers-100599140","NCT07080619","SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers","A Phase IIa Clinical Study to Assess the Efficacy and Safety of SC-101 in Patients With Advanced Malignant Tumors Positive for NECTIN4 Gene Amplification","Inclusion Criteria:\n\nAge between 18 and 75 years (inclusive), regardless of gender.\n\nECOG performance status of 0-1.\n\nExpected survival of more than 3 months, as assessed by the investigator.\n\nFertile participants must agree to use contraception.\n\nAble to understand the trial requirements and willing and able to comply with the trial and follow-up procedures.\n\nAdequate bone marrow and organ function.\n\nNECTIN-4 gene amplification positive.\n\nExclusion Criteria:\n\nUnstable central nervous system tumors.\n\nAdverse reactions from previous anticancer treatments have not recovered to a CTCAE 5.0 grade ≤1.\n\nA history of severe cardiovascular or cerebrovascular disease.",{"count":125,"type":20},120,[71],"This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.",[129,26],"TNBC - Triple-Negative Breast Cancer",[131],"SC-101","2025-09-04",{"date":134,"type":51},"2025-09-11",{"date":136,"type":20},"2025-09-20",{"date":138,"type":20},"2027-12-30",{"name":140,"class":58},"Tianjin ConjuStar Biologics Co., Ltd.",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":66,"minAge":17,"maxAge":67,"enrollmentInfo":148,"targetDuration":4,"studyType":150,"phases":4,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":116},"100572535","anlotinib-based-combination-therapy-in-patients-with-hormone-receptor-positivehr-metastatic-breast-cancermbc--100572535","NCT06734533","Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .","A New Option for Post-CDK4\u002F6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4\u002F6is.","Inclusion Criteria:\n\n* Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;\n* Presence of measurable lesions as defined by RECIST 1.1 criteria;\n* Histopathologically confirmed HR-positive\u002FHER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0\u002F1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;\n* Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;\n* Prior treatment with at least one line of CDK4\u002F6 inhibitors and endocrine therapy;\n* Disease progression following aromatase inhibitor (AI) or fulvestrant combined with CDK4\u002F6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease.\n\nExclusion Criteria:\n\n* Patients with HER2-positive breast cancer confirmed by histology or cytology;\n* Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;\n* Detection of a second primary malignant tumor at the time of enrollment;\n* Failure to complete CDK4\u002F6 inhibitor therapy;\n* Pregnant or breastfeeding patients;\n* Presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods;\n* Patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab;\n* Patients currently receiving any other anti-tumor treatment for any other malignancies.",{"count":149,"type":20},80,"OBSERVATIONAL","Cyclin-dependent kinases 4 and 6 (CDK4\u002F6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4\u002F6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4\u002F6 inhibitor.",[26],"2024-12-13",{"date":155,"type":51},"2024-12-16",{"date":157,"type":20},"2024-12-05",{"date":159,"type":20},"2025-12-30",{"name":161,"class":88},"Hunan Cancer Hospital"]