[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cdk46-inhibitor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cdk46-inhibitor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,66,95,116,179],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100641593","phase-1-in10018-in-combination-with-dalpiciclib-for-progressive-meningiomas-100641593",false,"NCT07652762","IN10018 in Combination With Dalpiciclib for Progressive Meningiomas","An Open-Label Phase Ib Clinical Study Evaluating the Safety, Tolerability, and Efficacy of IN10018 in Combination With Dalpiciclib in Participants With Progressive Meningiomas","Inclusion Criteria:\n\nInclusion Criteria:\n\nParticipants must be able to understand and willing to sign a written informed consent form and agree to comply with all study requirements. Written informed consent must be obtained before any study-related examination or procedure is performed.\n\nAged 18 years or older, male or female.\n\nHistologically confirmed meningioma meeting at least one of the following conditions:\n\n1. World Health Organization (WHO) Grade 2 or Grade 3 meningioma; or\n2. WHO Grade 1 meningioma that has recurred after surgery or radiotherapy and demonstrates clear radiographic or clinical progression, as determined by the investigator.\n\nNo available standard treatment option, or failure of standard treatment, including surgery, radiotherapy, or other systemic therapy.\n\nAt least 24 weeks must have elapsed since completion of radiotherapy, including external beam radiation therapy, brachytherapy, or radiosurgery such as Gamma Knife or CyberKnife.\n\nAt least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as confirmed by the investigator.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Estimated life expectancy of at least 3 months, as determined by the investigator.\n\nAdverse effects caused by previous treatments must have recovered to Grade 1 or lower according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia and fatigue.\n\nThe dose of corticosteroids or other hormonal treatment must have been stable for at least 4 days before enrollment.\n\nAdequate hematologic and organ function, based on laboratory tests performed within 7 days before the first dose, as follows:\n\nHematologic function:\n\n1. Hemoglobin of at least 100 g\u002FL, without dependence on red blood cell transfusion or erythropoietin.\n2. Platelet count of at least 100 × 10\\^9\u002FL, without dependence on platelet transfusion.\n3. Absolute neutrophil count of at least 1.5 × 10\\^9\u002FL, without the use of colony-stimulating factors.\n\n   Hepatic function:\n4. Total bilirubin no greater than the upper limit of normal.\n5. Alanine aminotransferase and aspartate aminotransferase no greater than 2.5 times the upper limit of normal.\n\n   Renal function:\n6. Serum creatinine no greater than 1.5 times the upper limit of normal.\n7. Either creatinine clearance calculated using the Cockcroft-Gault formula of at least 60 mL\u002Fmin or estimated glomerular filtration rate calculated using the Modification of Diet in Renal Disease formula of at least 60 mL\u002Fmin\u002F1.73 m².\n\n   Urinary protein and coagulation function:\n8. Urine protein negative or trace. Participants with urine protein of 1+ must have a morning spot urine protein-to-creatinine ratio of less than 0.5 or 24-hour urinary protein of less than 0.5 g\u002F24 hours.\n9. International normalized ratio no greater than 1.5 and activated partial thromboplastin time no greater than 1.5 times the upper limit of normal.\n\nFemale participants must not be pregnant or breastfeeding and must meet one of the following conditions:\n\n1. Not be a woman of childbearing potential; or\n2. If a woman of childbearing potential, agree to follow the protocol-specified contraceptive requirements during study treatment and for 3 months after the last dose.\n\nExclusion Criteria:\n\nMajor surgery or major trauma within 28 days before the first dose, or diagnostic biopsy within 14 days before the first dose.\n\nReceipt of systemic anticancer treatment, including an investigational drug, within the protocol-specified washout period, including chemotherapy or targeted therapy within 14 days or 5 half-lives before the first dose, whichever is shorter, or immunotherapy within 28 days before the first dose.\n\nPrevious treatment with a focal adhesion kinase inhibitor or a cyclin-dependent kinase 4\u002F6 inhibitor, including dalpiciclib.\n\nA serious cardiovascular event or clinically significant cardiovascular condition within 6 months before initiation of study treatment, including but not limited to:\n\n1. Left ventricular ejection fraction below 50%;\n2. Corrected QT interval greater than 480 milliseconds;\n3. New York Heart Association functional class 2 or higher;\n4. History of serious arrhythmia or cardiomyopathy. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Participants with small-volume effusions detectable only by imaging may be considered eligible.\n\nMalabsorption syndrome or inability to take oral medication. Serious gastrointestinal disease, including uncontrolled inflammatory gastrointestinal disease, active Crohn disease, active ulcerative colitis, or uncontrolled gastrointestinal bleeding.\n\nActive infection that is not adequately controlled by systemic treatment. Known human immunodeficiency virus infection. Human immunodeficiency virus testing is not required during screening unless mandated by local regulations or institutional policy.\n\nKnown active hepatitis B virus or hepatitis C virus infection. Hepatitis B virus and hepatitis C virus testing is not required during screening unless mandated by local regulations or institutional policy.\n\nAny medical history, treatment, laboratory abnormality, or other condition that, in the investigator's judgment, could confound interpretation of the study results, interfere with participant compliance, or compromise the participant's safety or interests.\n\nKnown psychiatric illness or substance abuse that could interfere with compliance with study requirements.\n\nKnown hypersensitivity to IN10018, dalpiciclib, or any component of either study drug.\n\nSystemic treatment with a strong inhibitor or inducer of CYP3A4, CYP2D6, or P-glycoprotein within 14 days before the first dose, or anticipated need for such treatment during the study treatment period.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Progressive meningiomas are tumors arising from the membranes surrounding the brain that have continued to grow or have returned after previous treatment.\n\nParticipants will receive both study drugs by mouth in 28-day treatment cycles. IN10018 will be taken once daily throughout each cycle, and dalpiciclib will be taken once daily for 21 days followed by 7 days without dalpiciclib. Treatment may continue until the tumor progresses, unacceptable side effects occur, or another reason for stopping treatment applies.\n\nThe study includes a dose-confirmation phase and a dose-expansion phase. The main goals are to evaluate side effects and determine a recommended dose of the combination for further study. Researchers will also assess whether the treatment can shrink tumors or delay tumor growth, measure how the drugs are processed in the body, and explore tumor and blood biomarkers that may be associated with treatment response.",[26,27],"Meningioma","CDK4\u002F6 Inhibitor","NOT_YET_RECRUITING","2026-06-11",{"date":31,"type":32},"2026-06-17","ACTUAL",{"date":34,"type":20},"2026-06",{"date":36,"type":20},"2029-08",{"name":38,"class":39},"Capital Medical University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100606833","breast-cancer-relapsed-in-patients-treated-with-adjuvant-cdk46-inhibitors-100606833","NCT07180693","Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4\u002F6 Inhibitors:","Breast Cancer RElapsed in Patients Treated With Adjuvant CDK4\u002F6 Inhibitors: Evaluation in the Real-world Setting","BREAKER","Inclusion Criteria:\n\n* Female (regardless of menopausal status) or male ≥18 years of age;\n* The patient has confirmed HR+, HER2-, early-stage resected invasive breast cancer candidate to adjuvant CDK4\u002F6 inhibitors (abemaciclib or ribociclib);\n* ER and PgR positivity is defined as evidence of immunohistochemical staining ≥ 1% according to ASCO\u002FCAP recommendations; HER2 negativity is defined as expression of the membrane protein in immunohistochemistry 0 or 1+ or with a 2+ in situ hybridization (ISH) test negative as per ASCO\u002FCAP recommendations;\n* Patients who are initiating or have initiated adjuvant treatment with a CDK4\u002F6 inhibitor (abemaciclib or ribociclib) in combination with endocrine therapy (ET). Treatment must have started on or after January 1, 2021.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;\n* Consent to data treatment according to the local regulation.\n\nExclusion Criteria:\n\n* Current participation in any other HR+\u002FHER2- EBC study with any investigational products;\n* Patients who have already received adjuvant treatment with a CDK4\u002F6 inhibitor as part of a clinical trial;\n* Patients unable to comply with the requirements of the study or who, in the judge of the study physician, should not be included in the study;\n* Patients with a history of previous BC, with the exception of Ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago;\n* Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the index date, will be excluded, as well.",{"count":50,"type":20},750,"OBSERVATIONAL","This is a multicenter observational study with both retrospective and prospective phase, designed to evaluate the clinico-pathologic characteristics and outcomes of patients with HR+\u002FHER2- EBC at high risk of recurrence treated with ribociclib or abemaciclib in combination with ET in the adjuvant setting.",[54,27],"Adjuvant Therapy","RECRUITING","2026-05-28",{"date":58,"type":32},"2026-05-29",{"date":60,"type":32},"2025-09-29",{"date":62,"type":20},"2030-08-01",{"name":64,"class":39},"European Institute of Oncology",18,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"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.","FEMALE",{"count":74,"type":20},2000,[76],"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.",[79,80,81,82,27,83],"Breast Diseases","Breast Neoplasms","Dalpiciclib","Endocrine Breast Diseases","HR+\u002FHER2- Breast Cancer","2026-05-06",{"date":86,"type":32},"2026-05-12",{"date":88,"type":32},"2026-01-21",{"date":90,"type":20},"2032-06-30",{"name":92,"class":93},"Fujian Cancer Hospital","OTHER_GOV",2,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":4},"100607599","development-of-a-new-remote-monitoring-model-for-patients-with-hrher2--breast-cancer-in-treatment-with-cdk46-inhibitors-and-hormone-therapy-100607599","NCT07190651","Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4\u002F6 Inhibitors and Hormone Therapy","VIRTUOSA","Inclusion Criteria:\n\n* Written informed consent.\n* Age ≥18 years old\n* Histologically or cytologically documented diagnosis of HR+, HER2-negative breast cancer based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent. HR+ tumor is defined as ER and\u002For PgR expression in greater than 1% of tumor cells. HER2-negative breast cancer is defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory).\n* Currently on treatment and have received ≥ 2 months of CDK4\u002F6i + hormone therapy as their initial endocrine based treatment for their metastatic disease in concordance with local CDK4\u002F6i label or treatment guideline.\n* No evidence of clinical or radiological disease progression per investigator assessment.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤2.\n\nExclusion Criteria:\n\n* History of significant neurological or psychiatric disorders that would prohibit the understanding and giving of informed consent.\n* Patient has a concurrent invasive malignancy and \u002For is concurrently using other anti-neoplastic therapy.",{"count":103,"type":20},50,"This study aims to develop and prospectively validate a questionnaire to select patients with breast cancer who need to access to hospital for clinical visit during treatment with CDK4\u002F6i, to improve patients' quality of life and reduce burden of hospital accesses.",[106,27],"Breast Cancer","2025-09-17",{"date":109,"type":32},"2025-09-24",{"date":111,"type":20},"2025-10-01",{"date":113,"type":20},"2026-09-30",{"name":115,"class":39},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":126,"conditions":127,"keywords":164,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":19},"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":125,"type":20},3500,"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.",[128,129,130,131,79,80,132,106,133,134,135,136,137,138,83,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,27,163],"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","Abemaciclib","CDK4\u002F6 Inhibitors",[165,166,160,161,162,167,168,169],"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":172,"type":32},"2025-02-03",{"date":174,"type":32},"2023-05-01",{"date":176,"type":20},"2040-12-31",{"name":178,"class":39},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":72,"minAge":17,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":21,"phases":189,"briefSummary":191,"conditions":192,"keywords":200,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":40},"100531268","safety-assessment-of-concurrent-radiotherapy-and-novel-systemic-therapy-for-breast-cancer-100531268","NCT06197581","Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer","RADIOCOM","Inclusion Criteria:\n\nECOG 0-2. Aged 18-70 years old. Pathologically diagnosed as breast cancer. Need to receive radiotherapy according to guidelines. Radiotherapy target volume included chest wall\u002Fbreast with or without lymph node regions.\n\nNeed to receive one of the following therapies according to guidelines, capetabine, CDK4\u002F6 inhibitor, PARP inhibitor , ICIs , HER2 inhibitors.\n\nExclusion Criteria:\n\nMale breast cancer. Allergy to the upper medicines before. Will receive trastuzumab alone during and\u002For after radiotherapy. With severe other disease.","70 Years",{"count":188,"type":20},148,[190],"NA","Radiation therapy is a crucial part in the comprehensive treatment of breast cancer. In recent years, emerging systemic treatment regimens such as HER 2 inhibitors, CDK 4\u002F6 inhibitors, PARP inhibitors, capecitabine and PD1 inhibitors have greatly improved the prognosis of breast cancer and has become the standard treatment for specific populations. A considerable number of patients require both radiotherapy and maintenance systemic therapy. However, it is not clear whether systemic therapy should be synchronized or suspended in radiotherapy，despite that previous basic research shows that some molecular drug therapy and radiotherapy has a clear synergy mechanism. There is an agent need for a definite evidence to evaluate the safety of synchronous treatment, to support clinical diagnosis and treatment and the next step of comprehensive treatment. The implementation of the new radiotherapy technology represented by IMRT takes into account the prescription dose homogenization and the minimization of normal tissue dosage, which provides a certain basis for the combination therapy. Based on the above conditions, this study intends to enroll patients between 18 and 70 years old with chest wall \u002F breast ± lymphatic drainage area and requiring capecitabine, CDK 4\u002F 6 inhibitor, HER2 targeted therapy or immunotherapy. Radiation and novel systemic therapies would be delivered concurrently. The study aimed at evaluating the safety of combined treatments.",[193,194,195,196,27,197,198,199],"Breast Cancer, Familial Male","Radiotherapy; Complications","Chemotherapeutic Toxicity","Immune Checkpoint Inhibitor","Trastuzumab","Pertuzumab","PARP Inhibitor",[106,201,202,203,197,198,204,205,206],"Radiotherapy","Adverse events","Capecitabine","Immune checkpoint inhibitor","CDK4\u002F6 inhibitor","PARP inhibitor","2024-08-19",{"date":209,"type":32},"2024-08-21",{"date":211,"type":32},"2024-01-12",{"date":213,"type":20},"2027-01-15",{"name":215,"class":39},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"]