{"commentary":{"count":225,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":104,"podcast":74,"x_thread":46,"x_video":1},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05169567\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"postMONARCH","nct_id":"NCT05169567","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=postmonarch-nct05169567. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"postMONARCH","arms":[{"description":"Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.","label":"Arm A: Abemaciclib plus Fulvestrant","type":"EXPERIMENTAL"},{"description":"Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.","label":"Arm B: Placebo plus Fulvestrant","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-12","type":"ESTIMATED"},"conditions":["Breast Neoplasm","Neoplasm Metastasis"],"enrollment":{"count":368,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Abemaciclib","type":"DRUG"},{"name":"Fulvestrant","type":"DRUG"},{"name":"Placebo","type":"DRUG"}],"last_update":"2026-10-06","lead_sponsor":"Eli Lilly and Company","official_title":"postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2024-02-08","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-Free Survival (PFS)","timeFrame":"Randomization to the date of first documented progression of disease or death from any cause (Up to 21 Months)"}],"references":[{"citation":"Zapatero-Solana E, Ding Y, Pulliam N, de Dios A, Ortiz-Ruiz MJ, Lallena MJ. Models of Early Resistance to CDK4/6 Inhibitors Unveil Potential Therapeutic Treatment Sequencing. Int J Mol Sci. 2025 Mar 14;26(6):2643. doi: 10.3390/ijms26062643.","pmid":"40141282","type":"DERIVED"},{"citation":"Kalinsky K, Bianchini G, Hamilton E, Graff SL, Park KH, Jeselsohn R, Demirci U, Martin M, Layman RM, Hurvitz SA, Sammons S, Kaufman PA, Munoz M, Lai JI, Knoderer H, Sandoval C, Chawla AR, Nguyen B, Zhou Y, Ravenberg E, Litchfield LM, Smyth L, Wander SA. Abemaciclib Plus Fulvestrant in Advanced Breast Cancer After Progression on CDK4/6 Inhibition: Results From the Phase III postMONARCH Trial. J Clin Oncol. 2025 Mar 20;43(9):1101-1112. doi: 10.1200/JCO-24-02086. Epub 2024 Dec 18.","pmid":"39693591","type":"DERIVED"}],"start_date":{"date":"2022-03-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer","url":"https://clinicaltrials.gov/study/NCT05169567"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/postmonarch-nct05169567"}