[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578376":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":35,"collaborators":24,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":24,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":24,"enrollmentInfo":48,"targetDuration":24,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":63,"whyStopped":24,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":24},{"fullName":5,"class":6},"Hubei Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"HR+\u002FHER2- breast cancer patients who are intolerance or insensitivity to neoadjuvant chemotherapy","EXPERIMENTAL","1. 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. 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.\n4. ECOG PS score 0-2",[13],"Drug: Ribociclib; abemaciclib; palbociclib; Dalpiciclib",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ribociclib; abemaciclib; palbociclib; Dalpiciclib","Neoadjuvant therapy: CDK4\u002F6 inhibitor combined with endocrine, a total of 6 cycles, 1 cycle every 28 days.\n\nCDK4\u002F6 inhibitors (choose one of the following four types):\n\n* Dalpiciclib 125 mg orally once a day d1-21 every 28 days for a cycle (3 weeks\u002F1 week off)\n* Palbociclib 125 mg orally once a day, d1-21, every 28 days in cycles (3 weeks\u002F1 week off)\n* Abemaciclib 150 mg orally twice daily in 28-day cycles (may be reduced to 100 mg orally twice daily if not tolerated)\n* Ribociclib 400 mg orally once a day in a 28-day cycle Endocrine therapy drugs: take according to the label. Premenopausal patients need to be treated for ovarian function suppression.",[9],[21,22,23],"Letrozole","Anastrozole","Esomeprazole",null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Hongmei Zheng, Doctor","CONTACT","+86 18971624606","zhenghongmeicj@163.com",{"name":32,"role":28,"phone":33,"phoneExt":24,"email":34},"Xinhong Wu, Doctor","+8618971624606","18971624606@163.com",{"type":36,"investigatorFullName":37,"investigatorTitle":38,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Hongmei Zheng, PhD","director","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":49,"type":50},40,"ESTIMATED","INTERVENTIONAL",[53],"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.",[56,57],"Breast Cancer Stage III","Breast Cancer Stage II",[59,60,61,62],"Hormone receptor (HR) positive","HER2 negative","neoadjuvant treatment","CDK4\u002F6 inhibitors","NOT_YET_RECRUITING","2025-03-14",{"date":66,"type":67},"2025-03-17","ACTUAL",{"date":69,"type":50},"2025-04-01",{"date":71,"type":50},"2027-12-01",{"name":37,"class":6}]