[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100518649":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":49,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":32,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Hunan Cancer Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CDK4\u002F6 inhibitors treatment",null,"All HR+\u002FHER2- metastatic breast cancer patients using CDK4\u002F6 inhibitors",[13],"Drug: Different treatment regimens following progression on CDK4\u002F6 inhibitors.",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Different treatment regimens following progression on CDK4\u002F6 inhibitors.","This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4\u002F6 inhibitors combined with endocrine therapy. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4\u002F6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be evaluated.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Ning Xie, Dr.","CONTACT","+860731-89762161","xiening@hnca.org.cn",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Ting Liu, Ms.","+860731-89762815","liuting@hnca.org.cn",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Changsha","Hunan","410013","China","CN",{"type":39,"coordinates":40},"Point",[41,42],112.97087,28.19874,{"lat":42,"lon":41},[45],{"name":46,"role":23,"phone":47,"phoneExt":10,"email":48},"Binliang Liu, M.D","073189762161","liubinliang_onco@163.com",{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100518649","real-world-study-on-cdk46-inhibitors-combined-with-endocrine-therapy-and-subsequent-treatment-in-hrher2--mbc-100518649",false,"NCT06033287","Real-World Study on CDK4\u002F6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+\u002FHER2- MBC.","Observational Real-World Study on the Efficacy, Safety, and Biomarker Exploration of CDK4\u002F6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+\u002FHER2- Metastatic Breast Cancer.","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  * Age ≥ 18 years, postmenopausal or pre\u002Fperimenopausal females, or male patients. Female patients must meet one of the following criteria:\n\n    1. Prior bilateral oophorectomy or age ≥ 60 years.\n    2. Age \\\u003C 60 with natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without any other pathological or physiological reasons), and estradiol (E2) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal range.\n    3. Pre\u002Fperimenopausal females may also be eligible but must be willing to receive LHRH agonist during the study.\n  * Pathologically confirmed HR-positive male\u002Ffemale breast cancer patients with evidence of localized recurrence or metastasis, who are not suitable for curative surgery or radiation therapy:\n\nER-positive and\u002For PR-positive defined as the proportion of positively stained tumor cells ≥ 1% of all tumor cells (as confirmed by the investigators at the participating center).\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* No prior systemic treatment or currently receiving CDK4\u002F6 inhibitors as first-line treatment for advanced disease.\n* Reproductive-age females must have a negative serum pregnancy test within 28 days before enrollment and male\u002Ffemale patients must be willing to use a medically approved highly effective contraceptive measure during the study period and up to 1 year after the last dose of investigational drug.\n* Non-pregnant or non-lactating females.\n* Not concurrently participating in any other ongoing study.\n* Patient or legally authorized representative has provided informed consent and is willing and able to comply with the planned visits, study treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n* 1\\. Any evidence of severe or uncontrolled systemic illnesses, including uncontrolled hypertension, active bleeding disorders, active infections including hepatitis B, hepatitis C, and human immunodeficiency virus, or severely impaired bone marrow reserve or organ function, including liver and kidney impairment, which, in the investigator's opinion, would greatly alter the risk\u002Fbenefit balance.\n* Patient has not yet recovered from any CTCAE grade ≥ 3 toxicity related to prior treatment at the start of CDK4\u002F6 inhibitor therapy.\n* Known history of allergy to CDK4\u002F6 inhibitors, excipients, or drugs with a similar chemical structure or class as CDK4\u002F6 inhibitors.\n* Patients deemed unsuitable for enrollment by the investigator.","ALL","18 Years",{"count":61,"type":62},300,"ESTIMATED","OBSERVATIONAL","Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4\u002F6i Progression in the Real World has significant implications. This study is an observational, real-world study. It plans to include over 300 eligible HR+\u002FHER2- metastatic breast cancer patients who are currently receiving or planning to receive endocrine therapy regimens containing CDK4\u002F6 inhibitors. This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4\u002F6 inhibitors combined with endocrine therapy, based on clinical guideline consensus. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4\u002F6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be chosen by the physician, and the efficacy and safety of subsequent treatment will be evaluated. Additionally, peripheral blood ctDNA testing will be used to assess changes in baseline and progression-related biomarkers, including ESR1, PI3KCA, FGFR1, PTEN, among some patients.",[66,67,68,69],"Breast Cancer","Endocrine Therapy","CDK4\u002F6 Inhibitors","Subsequent Treatment","2025-07-08",{"date":72,"type":73},"2025-07-11","ACTUAL",{"date":75,"type":73},"2023-01-01",{"date":77,"type":62},"2025-12-31",{"name":5,"class":6},1]