{"commentary":{"count":249,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":105,"podcast":83,"x_thread":61},"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\": \"NCT04305496\", \"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":"CAPItello-291","nct_id":"NCT04305496","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=capitello-291-nct04305496. 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":"CAPItello-291","arms":[{"description":"Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter.\n\nCapivasertib: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.","label":"Capivasertib + fulvestrant","type":"EXPERIMENTAL"},{"description":"Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter.\n\nPlacebo: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.","label":"Placebo + fulvestrant","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2026-06-22","type":"ESTIMATED"},"conditions":["Locally Advanced (Inoperable) or Metastatic Breast Cancer"],"enrollment":{"count":818,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Fulvestrant","type":"DRUG"},{"name":"Capivasertib","type":"DRUG"},{"name":"Placebo","type":"DRUG"}],"last_update":"2026-04-30","lead_sponsor":"AstraZeneca","official_title":"A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2023-05-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression Free Survival: Overall Population (Months) in the Global Cohort","timeFrame":"Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression."},{"measure":"Progression Free Survival: Overall Population (Percentage) in the Global Cohort","timeFrame":"Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression."},{"measure":"Progression Free Survival: Altered Population (Months) in the Global Cohort","timeFrame":"Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks."},{"measure":"Progression Free Survival: Altered Population (Percentage) in the Global Cohort","timeFrame":"Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks."},{"measure":"Progression Free Survival: Overall Population (Months) in the China Cohort","timeFrame":"Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression."},{"measure":"Progression Free Survival: Overall Population (Percentage) in the China Cohort","timeFrame":"Assessed every 8 weeks for the first 18 months and every 12 weeks thereafter, from randomization to radiological progression."},{"measure":"Progression Free Survival: Altered Population (Months) in the China Cohort","timeFrame":"Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks."},{"measure":"Progression Free Survival: Altered Population (Percentage) in the China Cohort","timeFrame":"Assessed every 8 weeks for the first 2 years following objective disease progression or treatment discontinuation and then every 12 weeks."}],"references":[{"citation":"Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez Moreno HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Park YH, Sohn J, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin EC, Grinsted L, Schiavon G, Foxley A, Rugo HS; CAPItello-291 Study Group. Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2023 Jun 1;388(22):2058-2070. doi: 10.1056/NEJMoa2214131.","pmid":"37256976","type":"BACKGROUND"},{"citation":"Turner NC, Oliveira M, Howell SJ, Dalenc F, Cortes J, Gomez HL, Hu X, Jhaveri K, Krivorotko P, Loibl S, Murillo SM, Park YH, Sohn JH, Toi M, Tokunaga E, Yousef S, Zhukova L, de Bruin E, Grinsted L, Schiavon G, Foxley A, Rugo HS. A plain language summary of the CAPItello-291 study: Capivasertib in hormone receptor-positive advanced breast cancer. Future Oncol. 2024;20(37):2901-2913. doi: 10.1080/14796694.2024.2390791. Epub 2024 Sep 16.","pmid":"39283299","type":"DERIVED"},{"citation":"Oliveira M, Rugo HS, Howell SJ, Dalenc F, Cortes J, Gomez HL, Hu X, Toi M, Jhaveri K, Krivorotko P, Loibl S, Morales Murillo S, Okera M, Nowecki Z, Park YH, Sohn JH, Tokunaga E, Yousef S, Zhukova L, Fulford M, Andrews H, Wadsworth I, D'Cruz C, Turner NC; CAPItello-291 study group. Capivasertib and fulvestrant for patients with hormone receptor-positive, HER2-negative advanced breast cancer (CAPItello-291): patient-reported outcomes from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2024 Sep;25(9):1231-1244. doi: 10.1016/S1470-2045(24)00373-5.","pmid":"39214106","type":"DERIVED"},{"citation":"Dilawari A, Buturla J, Osgood C, Gao X, Chen W, Ricks TK, Schaefer T, Avasarala S, Reyes Turcu F, Pathak A, Kalavar S, Bhatnagar V, Collazo J, Rahman NA, Mixter B, Tang S, Pazdur R, Kluetz P, Amiri-Kordestani L. US Food and Drug Administration Approval Summary: Capivasertib With Fulvestrant for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced or Metastatic Breast Cancer With PIK3CA/AKT1/PTEN Alterations. J Clin Oncol. 2024 Dec;42(34):4103-4113. doi: 10.1200/JCO.24.00427. Epub 2024 Aug 19.","pmid":"39159418","type":"DERIVED"}],"start_date":{"date":"2020-04-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer","url":"https://clinicaltrials.gov/study/NCT04305496"},"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/capitello-291-nct04305496"}