{"id":"fulvestrant-prefilled-syringe","safety":{"commonSideEffects":[{"rate":"25-40","effect":"Hot flashes"},{"rate":"15-25","effect":"Injection site pain/reaction"},{"rate":"20-30","effect":"Asthenia/fatigue"},{"rate":"15-25","effect":"Nausea"},{"rate":"10-20","effect":"Vaginal bleeding/discharge"},{"rate":"10-15","effect":"Headache"},{"rate":"10-15","effect":"Back pain"}]},"_chembl":{"chemblId":"CHEMBL4760678","moleculeType":"Unknown","molecularWeight":"606.78"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fulvestrant competitively binds to estrogen receptors with high affinity and causes their degradation through proteasomal pathways, eliminating both ligand-dependent and ligand-independent signaling. This mechanism differs from aromatase inhibitors by directly destroying the receptor rather than blocking estrogen production, making it effective in hormone receptor-positive breast cancers including those resistant to other endocrine therapies.","oneSentence":"Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors in hormone receptor-positive breast cancer cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:47:04.287Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer"},{"name":"Hormone receptor-positive breast cancer in postmenopausal women (first-line or subsequent lines of endocrine therapy)"}]},"trialDetails":[{"nctId":"NCT05038735","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.","status":"ACTIVE_NOT_RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2021-12-17","conditions":"Breast Cancer","enrollment":212},{"nctId":"NCT03620643","phase":"PHASE2","title":"Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours","status":"COMPLETED","sponsor":"Royal Marsden NHS Foundation Trust","startDate":"2019-05-09","conditions":"Lobular Breast Carcinoma, Gastric Cancer, Triple Negative Breast Cancer","enrollment":33},{"nctId":"NCT04158362","phase":"PHASE3","title":"Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"UNICANCER","startDate":"2020-06-11","conditions":"Cancer Metastatic","enrollment":180},{"nctId":"NCT04899349","phase":"PHASE2","title":"Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant","status":"TERMINATED","sponsor":"Novartis Pharmaceuticals","startDate":"2022-04-06","conditions":"Breast Cancer","enrollment":2},{"nctId":"NCT05905341","phase":"PHASE1","title":"Study of PF-07224826, as a Single Agent or in Combination With Endocrine Therapy in Participants With Breast Cancer and Other Advanced Solid Tumors.","status":"WITHDRAWN","sponsor":"Pfizer","startDate":"2024-01-15","conditions":"Breast Cancer, Ovarian Cancer, Liposarcoma","enrollment":""},{"nctId":"NCT03555877","phase":"PHASE2","title":"Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer","status":"COMPLETED","sponsor":"GBG Forschungs GmbH","startDate":"2018-03-15","conditions":"Breast Cancer Metastatic","enrollment":56},{"nctId":"NCT04852081","phase":"","title":"Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.","status":"UNKNOWN","sponsor":"Blokhin's Russian Cancer Research Center","startDate":"2021-01-01","conditions":"Breast Cancer Stage IV","enrollment":1000},{"nctId":"NCT04526028","phase":"","title":"Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China","status":"UNKNOWN","sponsor":"Tianjin Medical University Cancer Institute and Hospital","startDate":"2019-09-13","conditions":"Breast Cancer, Fulvestrant, Palbociclib","enrollment":612},{"nctId":"NCT01300351","phase":"PHASE3","title":"Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2011-03","conditions":"Breast Cancer","enrollment":249}],"_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":"Fulvestrant Prefilled Syringe","genericName":"Fulvestrant Prefilled Syringe","companyName":"UNICANCER","companyId":"unicancer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors in hormone receptor-positive breast cancer cells. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer, Hormone receptor-positive breast cancer in postmenopausal women (first-line or subsequent lines of endocrine therapy).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}