{"preliminary_commentary":{"by_channel":{"x_thread":8},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04895358\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"KEYNOTE-B49","nct_id":"NCT04895358","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=keynote-b49-nct04895358. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming 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: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\\^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\\^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.","label":"Pembrolizumab + Chemotherapy","type":"EXPERIMENTAL"},{"description":"Participants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m\\^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m\\^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m\\^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m\\^2 PO BID on Days 1-14 Q3W for up to 35 administrations.","label":"Placebo + Chemotherapy","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2027-12-18","type":"ESTIMATED"},"conditions":["Breast Neoplasms"],"enrollment":{"count":342,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"pembrolizumab","otherNames":["KEYTRUDA®","MK-3475"],"type":"BIOLOGICAL"},{"name":"paclitaxel","otherNames":["TAXOL®"],"type":"DRUG"},{"name":"nab-paclitaxel","otherNames":["ABRAXANE®"],"type":"DRUG"},{"name":"liposomal doxorubicin","otherNames":["DOXIL®"],"type":"DRUG"},{"name":"capecitabine","otherNames":["XELODA®"],"type":"DRUG"},{"name":"normal saline","otherNames":[],"type":"DRUG"},{"name":"dextrose","otherNames":[],"type":"DRUG"}],"last_update":"2026-07-22","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-04-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1","timeFrame":"Up to approximately 50 months"}],"references":[],"start_date":{"date":"2021-06-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)","url":"https://clinicaltrials.gov/study/NCT04895358"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/keynote-b49-nct04895358"}