[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550480":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":47,"responsibleParty":66,"collaborators":27,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":27,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":27,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Fudan University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm-A","EXPERIMENTAL","Apatinib combined with cdk4\u002F6i and Endocrine therapy.",[13,14,15],"Drug: Apatinib","Drug: CDK4\u002F6 Inhibitor","Drug: Aromatase inhibitor and Fulvestrant",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm-B","ACTIVE_COMPARATOR","cdk4\u002F6i and Endocrine therapy.",[14,15],[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Apatinib","Apatinib is a kind of TKI inhibitor.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"CDK4\u002F6 Inhibitor","Dalpiciclib (SHR6390) is a kind of CDK4\u002F6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.",[9,17],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Aromatase inhibitor and Fulvestrant","Endocrine therapy combined with CDK4\u002F6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.",[9,17],[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Zhimin Shao, MD, PhD","CONTACT","86-021-64175590","88807","zhimingshao@yahoo.com",{"name":44,"role":39,"phone":40,"phoneExt":45,"email":46},"Peng Ji, MD","62978","JIPENG_1010@163.COM",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":57,"coordinates":58},"Point",[59,60],121.45806,31.22222,{"lat":60,"lon":59},[63,65],{"name":64,"role":39,"phone":40,"phoneExt":41,"email":42},"Zhimin Shao Shao, MD, PhD",{"name":44,"role":39,"phone":40,"phoneExt":45,"email":46},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Zhimin Shao","Director of General Surgery of Fudan Shanghai Cancer Center","100550480","phase-3-apatinib-combined-with-cdk46i-in-first-line-treatment-for-hrher2--snf4-subtype-breast-cancer-100550480",false,"NCT06447623","Apatinib Combined With cdk4\u002F6i in First-line Treatment for HR+\u002FHER2- SNF4 Subtype Breast Cancer","Study of Efficacy of Apatinib Combined With cdk4\u002F6i in First-line Treatment for HR+\u002FHER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Patients need to meet all of the following conditions\n\n  * Patients must be ≥18 and ≤ 75 years of age;\n  * Pathologically confirmed breast cancer is HR+\u002FHER2- breast cancer (IHC ER \\>10%, or\u002Fand PR\\>10%, HER 0 OR +, if HER2++, FISH negative);\n  * SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H\\&E sections;\n  * Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4\u002F6 inhibitors in the past, or one year after adjuvant CDK4\u002F6 inhibitor therapy has ended);\n  * No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;\n  * Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1;\n  * The functions of the main organs are basically normal, and the following conditions are met:\n\n    1. Blood routine examination standards should meet: HB≥90g\u002FL (no blood transfusion within 14 days); ANC≥1.5×109\u002FL; PLT≥75×109\u002FL;\n    2. Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance \\> 50ml\u002Fmin (Cockcroft-Gault formula);\n  * ECOG performance status 0 or 1; The expected survival is more than 3 months;\n  * Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;\n  * Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n* Patients with any of the following conditions were excluded from the study\n\n  * Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).\n  * A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;\n  * Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+\u002FHER2- breast cancer within 4 weeks before the first administration of drugs used in this study.\n  * Pregnant or lactating patients;\n  * Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;\n  * Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient\\'s participation in the study;\n  * Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;\n  * The investigator does not consider the patient suitable for participation in any other circumstances of the study.","FEMALE","18 Years","75 Years",{"count":81,"type":82},184,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+\u002F HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.",[88,89],"Advanced Breast Cancer","HR+\u002FHER2- Breast Cancer",[91,88],"HR+\u002FHER2- breast cancer","2024-06-03",{"date":94,"type":95},"2024-06-07","ACTUAL",{"date":97,"type":95},"2024-02-01",{"date":99,"type":82},"2029-02-01",{"name":5,"class":6},1]