{"commentary":{"count":12,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":7,"youtube":2,"podcast":2,"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\": \"NCT04158362\", \"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":"AMBRE","nct_id":"NCT04158362","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=ambre-nct04158362. 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":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":"AMBRE","arms":[{"description":"\\* Paclitaxel: administrated at the dose of 80 mg/m² as a 1-hour intravenous infusion every week (i.e., D1, D8 and D15) of a 3-week cycle.\n\nOR\n\n\\* Capecitabine: given orally at a dose of 2000 to 2500 mg/m² daily for 14 days followed by a 7-day rest period every 3 weeks.","label":"Standard Chemotherapy regimen","type":"EXPERIMENTAL"},{"description":"\\* Letrozole: continuous orally administration of 2.5 mg/day (1 tablet/day) OR anastrozole continuous orally administration of 1 mg/day (1 tablet/day) in combination with oral abemaciclib 150 mg (BID: twice a day) continuous for patients NSAI naïve or relapsing \\>1 year after the end of adjuvant ET.\n\nOR\n\n\\* Fulvestrant: 500 mg intramuscular on D1-D15-D29 (loading dose). Then 500 mg every 28 days (maintenance dose) with oral abemaciclib 150 mg BID continuous for patients relapsing on adjuvant or less than one year after completion of adjuvant NSAI.\n\nFor women with a non-menopausal status at inclusion, a concomitant Luteinizing hormone-releasing hormone (LH-RH) agonist will be administered in combination with ET every 28 days. The LH-RH agonist drug to be used will be left to the investigator's choice.","label":"Standard Endocrine therapy (ET) regimen + Abemaciclib","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2032-06","type":"ESTIMATED"},"conditions":["Cancer Metastatic"],"enrollment":{"count":180,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Paclitaxel injection","type":"DRUG"},{"name":"Capecitabine tablets","type":"DRUG"},{"name":"Letrozole 2.5mg","type":"DRUG"},{"name":"Anastrozole 1mg","type":"DRUG"},{"name":"Fulvestrant Prefilled Syringe","type":"DRUG"},{"name":"Abemaciclib","type":"DRUG"}],"last_update":"2026-07-22","lead_sponsor":"UNICANCER","official_title":"Open-label, Randomized, Multicenter, Phase III Study, Comparing Standard Chemotherapy to Standard Combination of Endocrine Therapy With Abemaciclib as Initial Metastatic Treatment Among Patients With Visceral Metastasis of ER+ HER2-breast Cancer, High Burden Disease","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2025-04-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free survival (PFS)","timeFrame":"From randomization to the date of the first documented progression (RECIST v1.1) or death from any cause up to 48 months"}],"references":[],"start_date":{"date":"2020-06-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer","url":"https://clinicaltrials.gov/study/NCT04158362"},"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/ambre-nct04158362"}