[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hongmei Zheng, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100578376","the-efficacy-and-safety-of-cdk46-inhibitors-in-combination-with-endocrine-therapy-in-the-neoadjuvant-treatment-100578376",false,"NCT06810492","The Efficacy and Safety of CDK4\u002F6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment","A Single-arm Exploratory Study of the Efficacy and Safety of CDK4\u002F6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+\u002FHER2- Early Breast Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and\u002For multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and\u002For PR\\>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test).\n3. Patients must have histologically confirmed ER and\u002For PR \\>10%, HER2-, early invasive breast cancer.\n4. Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD\u002FSD, advanced age, and inability to tolerate chemotherapy with underlying diseases.\n5. ECOG PS score 0-2.\n6. Patients must be able and willing to swallow and retain oral medications.\n7. Premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test.\n8. Patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy.\n9. Absolute neutrophil count ≥ 1500\u002FµL, platelet ≥ 100000\u002Fmm3, hemoglobin ≥ 10g\u002FdL\n\nExclusion Criteria:\n\n1. Prior treatment with any CDK inhibitor.\n2. Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.\n3. History of anaphylaxis caused by chemical or biologic components similar to dalsily.\n4. Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.\n5. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n6. Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission.\n7. Patients with any history of malignancy are not eligible.\n8. Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","To explore the efficacy and safety of CDK4\u002F6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive\u002FHER2-negative breast cancer.\n\nThis study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+\u002FHER2- breast cancer.",[26,27],"Breast Cancer Stage III","Breast Cancer Stage II",[29,30,31,32],"Hormone receptor (HR) positive","HER2 negative","neoadjuvant treatment","CDK4\u002F6 inhibitors","NOT_YET_RECRUITING","2025-03-14",{"date":36,"type":37},"2025-03-17","ACTUAL",{"date":39,"type":20},"2025-04-01",{"date":41,"type":20},"2027-12-01",{"name":43,"class":44},"Hongmei Zheng, PhD","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":4,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100519942","the-benefits-of-continued-use-of-ovarian-function-suppression-after-5-years-100519942","NCT06050109","The Benefits of Continued Use of Ovarian Function Suppression After 5 Years","A Multicenter, Open-label, Non-randomized Controlled Real World Study Comparing the Benefits of Continued Use of Ovarian Function Suppression After 5 Years","Inclusion Criteria:\n\n* Diagnosed with early primary breast cancer\n* Female aged 18-60 years (including 18 year and 60 year)\n* Hormone receptor (HR) positive HER2 negative\n* Receive 5 years of OFS treatment\n* ECOG score 0-1\n* Voluntarily join this study and sign the informed consent form;\n* The researcher believes that it can benefit.\n\nExclusion Criteria:\n\n* The patient is receiving treatment that affects OFS at the same time The patient has received OFS treatment for less than 5 years\n* Central nervous system metastases with known obvious symptoms, such as headache, cerebral edema, blurred vision\n* Invasive metastases with known obvious symptoms\n* Invasive metastases with known obvious symptoms\n* Doctors think it is not suitable for inclusion","FEMALE","60 Years",{"count":55,"type":20},1200,"OBSERVATIONAL","To observe and evaluate the clinical efficacy and safety of continuous use of OFS for premenopausal patients with early breast cancer after 5 years use of OFS.\n\nThis study is a multicenter, prospective, observational, non randomized controlled, open-label real world study based on hospital medical record system data, aimed at evaluating the benefits of continuing to use OFS after 5 years of use. The retrospective analysis plan includes patient data from September 1, 2023 to September 1, 2026. Join two cohorts: the continued use group and the discontinued use group after 5 years of OFS, respectively.",[59,60],"Breast Cancer Female","Endocrine Therapy",[62,29,30,63,64],"ovarian function suppression","early breast cancer","prolonged therapy","RECRUITING",{"date":36,"type":37},{"date":68,"type":37},"2023-09-01",{"date":70,"type":20},"2028-09-01",{"name":43,"class":44},1,""]