[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hrher2--early-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hrher2--early-breast-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,64,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100639184","phase-2-efficacy-and-safety-of-culmerciclib-plus-aromatase-inhibitors-in-a-response-adapted-neoadjuvant-strategy-for-highly-proliferative-er-positiveher2-negative-breast-cancer-100639184",false,"NCT07616453","Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive\u002FHER2-Negative Breast Cancer","Neoadjuvant Trastuzumab-rezetecan Plus Pertuzumab or Nab-Paclitaxel, Carboplatin, Trastuzumab, and Pyrotinib After Suboptimal Response to Neoadjuvant Dual HER2-Targeted Therapy Combined With Chemotherapy in HER2-Positive Early Breast Cancer: A Response-Guided Phase II Study (TAYLOR-002)","TAYLOR-002","Inclusion Criteria Female patients aged ≥18 and ≤75 years. Histologically confirmed estrogen receptor (ER)-positive (≥10%) and HER2-negative breast cancer, according to the 2018 ASCO\u002FCAP guidelines. HER2-negative status is defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with negative in situ hybridization (ISH) (ISH ratio \\\u003C2.0), as confirmed by a certified pathology laboratory.\n\nKi-67 ≥20% assessed on core needle biopsy samples. Newly diagnosed, treatment-naïve patients with stage I-IIIA disease according to the AJCC 8th edition.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nAdequate bone marrow function:\n\n1. Absolute neutrophil count ≥1.5 × 10⁹\u002FL (without growth factor support within 14 days);\n2. Platelet count ≥100 × 10⁹\u002FL (without transfusion or supportive therapy within 7 days);\n3. Hemoglobin ≥100 g\u002FL (without transfusion within 7 days).\n\nAdequate hepatic and renal function:\n\n1. Total bilirubin ≤1 × upper limit of normal (ULN);\n2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN in patients with liver metastases);\n3. Blood urea nitrogen and serum creatinine ≤1.5 × ULN, and creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n\nLeft ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography. QT interval ≤480 ms on 12-lead electrocardiogram (ECG). Ability and willingness to undergo tumor biopsy. Provision of written informed consent. Exclusion Criteria Prior receipt of any anticancer therapy, including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy.\n\nConcurrent treatment with other anticancer agents. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. Stage IV breast cancer. Breast cancer not confirmed by histopathology. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix.\n\nSevere dysfunction of major organs, including heart, liver, or kidneys. Conditions affecting oral drug administration or absorption, including inability to swallow, chronic diarrhea, or intestinal obstruction.\n\nParticipation in another interventional clinical trial within 4 weeks prior to enrollment.\n\nKnown hypersensitivity to any component of the study drugs; history of immunodeficiency, including HIV infection, active hepatitis B or C infection, other acquired or congenital immunodeficiency disorders, or history of organ transplantation.\n\nHistory of significant cardiovascular disease, including but not limited to clinically significant arrhythmias requiring treatment, myocardial infarction, heart failure, or any other cardiac condition deemed unsuitable by the investigator.\n\nPregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at baseline, or unwilling to use effective contraception during the study period.\n\nAny serious concomitant disease that, in the investigator's judgment, may compromise patient safety or compliance with the study, including but not limited to uncontrolled hypertension, severe diabetes, or active infection.\n\nHistory of neurological or psychiatric disorders, including epilepsy or dementia.\n\nAny other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study.","FEMALE","18 Years","75 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive\u002FHER2-negative breast cancer. All patients initially receive induction treatment with culmerciclib plus endocrine therapy, followed by on-treatment assessment of biological and clinical response. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to alternative treatment strategies prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and avoid unnecessary exposure to ineffective therapy.",[28],"HR+\u002FHER2- Early Breast Cancer","RECRUITING","2026-05-24",{"date":32,"type":33},"2026-06-01","ACTUAL",{"date":35,"type":22},"2026-05-06",{"date":37,"type":22},"2033-05-05",{"name":39,"class":40},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100633823","patient-relevant-outcomes-improvement-program-in-high-risk-hormone-receptor-positive-hr-breast-cancer-100633823","NCT07531693","Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer","Patient Relevant Outcomes Improvement Program in High Risk HR-positive Breast Cancer","PROSPER","Inclusion Criteria:\n\n* Femal patients age 18 or older at time of informed consent\n* Confirmed diagnosis of HR+\u002FHER2- early breast cancer (no distant metastasis)\n* Prescribed abemaciclib therapy according to the Summary of Product Characteristics (SmPC)\n* Abemaciclib therapy occured between January 1st, 2023 and June 30th, 2025\n\nExclusion Criteria:\n\n* Locally advanced or metastatic breast cancer\n* Male patients\n* Patients with contraindication(s) for abemaciclib therapy according to SmPC",{"count":51,"type":22},200,"OBSERVATIONAL","The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start. To this end, researchers will perform a retrospective analysis of therapy data.",[28],"2026-05-11",{"date":57,"type":33},"2026-05-14",{"date":59,"type":33},"2026-02-19",{"date":61,"type":22},"2027-03",{"name":63,"class":40},"Institut fuer Frauengesundheit",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":74,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100633016","implementing-patients-competence-in-oral-ebc-therapy-persistence-100633016","NCT07521202","IMPLEMENTING PATIENTS' COMPETENCE IN ORAL EBC THERAPY PERSISTENCE","A Scientific Study Evaluating Therapy Persistence in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer Under Adjuvant Treatment With Abemaciclib Who Receive Standardized Patient Education and Counselling.","IMPACT PT","Inclusion Criteria:\n\n* Women age 18 or older at time of ICF signature\n* Patients with HRpos\u002FHER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago\n* Patients treated with abemaciclib according to the SmPC and each center´s medical practice\n* Informed consent given prior to the starting study activities\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Patients with contraindications against abemaciclib according to the current SmPC\n* Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician",{"count":73,"type":22},257,[75],"NA","The goal of this interventional study is to evaluate the effect of standardized patient coaching on treatment adherence among patients taking abemaciclib.\n\nThe main question it aims to answer is, whether standardized coaching leads to patients taking abemaciclib much more consistently. Researchers will therefore compare therapy adherence of patients receiving standardized coaching to patients receiving routine care.\n\nParticipants will be asked to answer several questionnaires.",[28],"NOT_YET_RECRUITING","2026-04-07",{"date":81,"type":33},"2026-04-09",{"date":83,"type":22},"2026-06",{"date":85,"type":22},"2030-06",{"name":63,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":95,"minAge":18,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"100577379","rwe-non-interventional-prospective-study-of-ribociclib-effectiveness-and-safety-in-patients-with-hrher2--early-breast-cancer-in-saudi-arabia-100577379","NCT06797531","RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+\u002FHER2- Early Breast Cancer in Saudi Arabia","Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+\u002FHER2- Early Breast Cancer in Saudi Arabia","NISLEESA","Inclusion Criteria:\n\n1. Signed and dated Patient Informed Consent Form (PICF) obtained.\n2. The patient is ≥ 18 years-old at the time of PICF signature.\n3. Male or female patients with estrogen-receptor-positive and\u002For progesterone-receptor-positive BC.\n4. Male or female patients with HER2- BC.\n5. Patients who are currently receiving ribociclib in combination with adjuvant ET as per approved local label for up to 6 months prior the enrollment date.\n6. Male or female patients with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA(subset) \u002FIIB or Anatomic Stage Group III EBC.\n7. Female patients with known menopausal status (at the time of PICF signature or initiation of adjuvant ET, whichever occurs earlier), or male.\n\nExclusion Criteria:\n\n1. Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.\n2. Patients are currently participating in any other clinical trials.\n3. Patients who previously received any other CDK4\u002F6 inhibitor.\n4. Patients who refused to sign informed consent.\n5. According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and\u002For to obtain long-term follow-up information for any reason.","ALL","99 Years",{"count":98,"type":22},177,"This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+\u002FHER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in Saudi Arabia.",[28],[102,103,104,105,106,107,108,109],"Early breast cancer","Saudi Arabia","Ribociclib","Effectiveness","Safety","Real world evidence","RWE","Observational study","2026-02-02",{"date":112,"type":33},"2026-02-04",{"date":114,"type":33},"2025-08-27",{"date":116,"type":22},"2028-11-30",{"name":118,"class":119},"Novartis Pharmaceuticals","INDUSTRY",2]