[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572535":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":12,"locations":18,"responsibleParty":36,"collaborators":7,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":7,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":7,"studyType":51,"phases":7,"briefSummary":52,"conditions":53,"keywords":7,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},{"fullName":5,"class":6},"Hunan Cancer Hospital","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Anlotinib+eribulin\u002Fnab-paclitaxel\u002Fetoposide\u002Fcapecitabine\u002Fpembrolizumab\u002F sintilimab\u002F fulvestrant, etc","Anlotinib (8\u002F10\u002F12 mg daily, Day 1-14 of each cycle) was administered orally to fasting patients, with dose reductions to 10 mg or 8 mg in cases of intolerable toxicity. Combination agents included eribulin, nab-paclitaxel, etoposide, capecitabine, pembrolizumab, sintilimab, or fulvestrant, among others.",[13],{"name":14,"role":15,"phone":16,"phoneExt":7,"email":17},"Quchang Ouyang","CONTACT","15676789890","tgzybc@163.com",[19],{"facility":20,"status":21,"city":22,"state":23,"zip":7,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Hunan Provincial Tumor Hospital","RECRUITING","Changsha","Hunan","China","CN",{"type":27,"coordinates":28},"Point",[29,30],112.97087,28.19874,{"lat":30,"lon":29},[33],{"name":34,"role":15,"phone":35,"phoneExt":7,"email":17},"Li","15616453102",{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100572535","anlotinib-based-combination-therapy-in-patients-with-hormone-receptor-positivehr-metastatic-breast-cancermbc--100572535",false,"NCT06734533","Anlotinib-based Combination Therapy in Patients with Hormone Receptor-positive（HR+） Metastatic Breast Cancer(MBC) .","A New Option for Post-CDK4\u002F6is Resistance Era: Multicenter Real-world Study of Anlotinib-based Combination Therapy in Hormone Receptor-positive Metastatic Breast Cancer Resistant to CDK4\u002F6is.","Inclusion Criteria:\n\n* Female patients aged 18 to 75 years, with an ECOG score of 0-1, and an expected survival of at least 3 months;\n* Presence of measurable lesions as defined by RECIST 1.1 criteria;\n* Histopathologically confirmed HR-positive\u002FHER2-negative breast cancer. HER2 negativity is determined by an immunohistochemistry (IHC) result of HER2 (0\u002F1+). If the result is HER2 (++), a FISH or CISH test is required to confirm the absence of HER2 amplification;\n* Patients who have undergone multiple lines of advanced therapy with no remaining standard treatment options;\n* Prior treatment with at least one line of CDK4\u002F6 inhibitors and endocrine therapy;\n* Disease progression following aromatase inhibitor (AI) or fulvestrant combined with CDK4\u002F6 inhibitors, either as adjuvant therapy or as systemic treatment for advanced disease.\n\nExclusion Criteria:\n\n* Patients with HER2-positive breast cancer confirmed by histology or cytology;\n* Patients who discontinued therapy due to non-disease progression reasons, such as adverse events or other non-medical factors;\n* Detection of a second primary malignant tumor at the time of enrollment;\n* Failure to complete CDK4\u002F6 inhibitor therapy;\n* Pregnant or breastfeeding patients;\n* Presence of third-space fluid accumulation (e.g., pleural effusion, ascites, pericardial effusion) that cannot be managed through drainage or other methods;\n* Patients previously treated with anti-angiogenic agents, including small molecules such as anlotinib or apatinib, and large molecules such as bevacizumab;\n* Patients currently receiving any other anti-tumor treatment for any other malignancies.","FEMALE","18 Years","75 Years",{"count":49,"type":50},80,"ESTIMATED","OBSERVATIONAL","Cyclin-dependent kinases 4 and 6 (CDK4\u002F6) inhibitors combined with hormonal therapy are the current standard frontline treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER-2)-negative metastatic breast cancer (MBC). However, the optimal treatment after progression on CDK4\u002F6 inhibitors remains unknown. Anlotinib is an oral multi-target tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. This study aimed to evaluate the safety and efficacy of anlotinib-based combination therapy in patients with HR+ MBC previously treated with a CDK4\u002F6 inhibitor.",[54],"HR+ Breast Cancer","2024-12-13",{"date":57,"type":58},"2024-12-16","ACTUAL",{"date":60,"type":50},"2024-12-05",{"date":62,"type":50},"2025-12-30",{"name":5,"class":6},1]