[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542113":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":24,"collaborators":10,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":21,"eligibilityCriteria":33,"healthyVolunteers":30,"sex":34,"minAge":35,"maxAge":10,"enrollmentInfo":36,"targetDuration":10,"studyType":39,"phases":10,"briefSummary":40,"conditions":41,"keywords":45,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":10},{"fullName":5,"class":6},"Helwan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Primary resistant to endocrine therapy",null,"Primary endocrine resistance is defined as a relapse within 2 years of adjuvant endocrine treatment or disease progression during the first 6 months of first-line endocrine therapy for advanced or MBC",[13],"Drug: Palbociclib",{"label":15,"type":10,"description":16,"interventionNames":17},"Secondary resistant to endocrine therapy","Secondary resistance is defined in early BC as a relapse that occurs after at least 2 years of endocrine therapy and during or within the first year of completing adjuvant endocrine therapy. In advanced BC or MBC, secondary resistance is defined as disease progression after more than 6 months of endocrine therapy",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Palbociclib","3 weeks on, 1 week off",[9,15],{"type":25,"investigatorFullName":26,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Yassmin Genina","Assistant lecturer at Faculty of Pharmacy","100542113","palbociclib-in-metastatic-breast-cancer-gene-polymorphism-based-study-in-egyptian-patients-100542113",false,"NCT06338644","Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.","Inclusion Criteria:\n\n* 1\\. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive\u002FHER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.\n\n  4\\. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.\n\nExclusion Criteria:\n\n1. Prior exposure to fulvestrant or everolimus.\n2. Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.\n3. Patients refusing to sign the written informed consent.","FEMALE","18 Years",{"count":37,"type":38},100,"ESTIMATED","OBSERVATIONAL","Cyclin-dependent kinase (CDK) 4\u002F6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies",[42,43,44],"Hormone-receptor-positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Metastatic Breast Cancer",[46],"Metastatic breast Cancer, Palbociclib, Pharmacogenomic","NOT_YET_RECRUITING","2024-03-24",{"date":50,"type":51},"2024-03-29","ACTUAL",{"date":53,"type":38},"2024-07-01",{"date":55,"type":38},"2026-09-01",{"name":5,"class":6}]