{"id":"dalpiciclib-capecitabine-endocrine-therapy","safety":{"commonSideEffects":[{"rate":"30-50%","effect":"Diarrhea"},{"rate":"20-40%","effect":"Nausea"},{"rate":"20-40%","effect":"Fatigue"},{"rate":"10-30%","effect":"Vomiting"},{"rate":"10-30%","effect":"Hand-foot syndrome"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Dalpiciclib works by inhibiting the CDK4/6 enzymes, which are involved in cell cycle progression. Capecitabine is a prodrug that is converted into 5-fluorouracil, a chemotherapy agent that interferes with DNA synthesis. Endocrine therapy, in this case, likely involves targeting hormone receptors such as estrogen receptors to slow cancer growth.","oneSentence":"Dalpiciclib is a CDK4/6 inhibitor that blocks the cell cycle, while capecitabine is a chemotherapy medication that interferes with DNA synthesis, and endocrine therapy targets hormone receptors to slow cancer growth.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:08:36.114Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HR-positive, HER2-negative advanced or metastatic breast cancer"}]},"trialDetails":[{"nctId":"NCT07467330","phase":"PHASE3","title":"Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment","status":"RECRUITING","sponsor":"Fujian Cancer Hospital","startDate":"2025-11-15","conditions":"Breast Cancer","enrollment":258},{"nctId":"NCT07005557","phase":"PHASE3","title":"Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer","status":"NOT_YET_RECRUITING","sponsor":"Fudan University","startDate":"2025-06-15","conditions":"Breast Cancer, Adjuvant Therapy","enrollment":1244},{"nctId":"NCT06176534","phase":"PHASE2","title":"Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial","status":"RECRUITING","sponsor":"Henan Cancer Hospital","startDate":"2024-01-01","conditions":"Advanced Breast Cancer, Treatment, HR Low/HER2 Negative","enrollment":240},{"nctId":"NCT05861830","phase":"PHASE3","title":"Dalpiciclib With Endocrine Therapy for Advanced Breast Cancer After CDK4/6 Inhibitor Failure (DAWNA-FES)","status":"RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2023-05-15","conditions":"Advanced Breast Cancer","enrollment":80}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"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_3","status":"active","brandName":"dalpiciclib + capecitabine + endocrine therapy","genericName":"dalpiciclib + capecitabine + endocrine therapy","companyName":"Fujian Cancer Hospital","companyId":"fujian-cancer-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Dalpiciclib is a CDK4/6 inhibitor that blocks the cell cycle, while capecitabine is a chemotherapy medication that interferes with DNA synthesis, and endocrine therapy targets hormone receptors to slow cancer growth. Used for HR-positive, HER2-negative advanced or metastatic breast cancer.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}