{"id":"initiation-of-ribociclib","safety":{"commonSideEffects":[{"rate":"45%","effect":"Fatigue"},{"rate":"39%","effect":"Nausea"},{"rate":"35%","effect":"Diarrhea"},{"rate":"34%","effect":"Vomiting"},{"rate":"32%","effect":"Leukopenia"},{"rate":"29%","effect":"Anemia"},{"rate":"26%","effect":"Thrombocytopenia"},{"rate":"25%","effect":"Neutropenia"},{"rate":"24%","effect":"Headache"},{"rate":"22%","effect":"Dizziness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Ribociclib works by inhibiting the cyclin-dependent kinases CDK4 and CDK6, which are involved in the progression of the cell cycle. This leads to a decrease in the proliferation of cancer cells.","oneSentence":"CDK4/6 inhibitor","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:36:43.750Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer"}]},"trialDetails":[{"nctId":"NCT07274709","phase":"","title":"Emulation of the MONALEESA-2 Trial Using Specialty Oncology Electronic Health Records Databases","status":"COMPLETED","sponsor":"Shirley Vichy Wang","startDate":"2025-09-07","conditions":"Advanced Breast Cancer","enrollment":2495},{"nctId":"NCT06830720","phase":"","title":"A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-02-20","conditions":"Breast Neoplasms","enrollment":3250},{"nctId":"NCT06797531","phase":"","title":"RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-08-27","conditions":"HR+/HER2- Early Breast Cancer","enrollment":177},{"nctId":"NCT05826964","phase":"PHASE2","title":"Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of Miami","startDate":"2023-06-12","conditions":"Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer","enrollment":24},{"nctId":"NCT07214532","phase":"NA","title":"Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Natera, Inc.","startDate":"2026-03","conditions":"Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)","enrollment":725},{"nctId":"NCT05977036","phase":"NA","title":"BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer","status":"RECRUITING","sponsor":"Washington University School of Medicine","startDate":"2024-09-25","conditions":"Metastatic Breast Cancer, Unresectable Breast Cancer","enrollment":65},{"nctId":"NCT05429502","phase":"PHASE1","title":"Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2022-12-27","conditions":"Neuroblastoma","enrollment":12},{"nctId":"NCT07072013","phase":"","title":"An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2023-09-08","conditions":"Breast Cancer","enrollment":1937}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":146,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_2","status":"active","brandName":"Initiation of ribociclib","genericName":"Initiation of ribociclib","companyName":"Shirley Vichy Wang","companyId":"shirley-vichy-wang","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CDK4/6 inhibitor Used for Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}