{"commentary":{"count":134,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":49,"podcast":45,"x_thread":40},"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\": \"NCT03725059\", \"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":"NCT03725059","nct_id":"NCT03725059","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03725059. 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":null,"arms":[{"description":"In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m\\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\\^2 or 100 mg/m\\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.","label":"Pembrolizumab+Chemotherapy (KX/KA[E]C)","type":"EXPERIMENTAL"},{"description":"In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m\\^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m\\^2 or 100 mg/m\\^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m\\^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.","label":"Placebo+Chemotherapy (PX/PA[E]C)","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2031-01-24","type":"ESTIMATED"},"conditions":["Breast Cancer"],"enrollment":{"count":1240,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pembrolizumab (K)","type":"BIOLOGICAL"},{"name":"Placebo (P)","type":"DRUG"},{"name":"Paclitaxel (X)","type":"DRUG"},{"name":"Doxorubicin (A)","type":"DRUG"},{"name":"Epirubicin (E)","type":"DRUG"},{"name":"Cyclophosphamide (C)","type":"DRUG"},{"name":"Endocrine therapy","type":"DRUG"},{"name":"Radiation therapy","type":"RADIATION"},{"name":"Surgery","type":"PROCEDURE"}],"last_update":"2025-07-11","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2031-01-24","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0","timeFrame":"Up to approximately 7 months (Time of surgery)"},{"measure":"Event-Free Survival (EFS)","timeFrame":"Up to approximately 12 years"}],"references":[{"citation":"Cardoso F, O'Shaughnessy J, Liu Z, McArthur H, Schmid P, Cortes J, Harbeck N, Telli ML, Cescon DW, Fasching PA, Shao Z, Loirat D, Park YH, Fernandez MG, Rubovszky G, Spring L, Im SA, Hui R, Takano T, Andre F, Yasojima H, Ding Y, Jia L, Karantza V, Tryfonidis K, Bardia A. Pembrolizumab and chemotherapy in high-risk, early-stage, ER+/HER2- breast cancer: a randomized phase 3 trial. Nat Med. 2025 Feb;31(2):442-448. doi: 10.1038/s41591-024-03415-7. Epub 2025 Jan 21.","pmid":"39838117","type":"RESULT"},{"citation":"Schlam I, Corti C, Sammons S, Mittendorf EA, Tolaney SM. Checkpoint inhibition for early-stage hormone receptor-positive breast cancer. Expert Opin Biol Ther. 2024 Jun;24(6):511-520. doi: 10.1080/14712598.2024.2370395. Epub 2024 Jun 24.","pmid":"38913933","type":"DERIVED"}],"start_date":{"date":"2018-12-27","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)","url":"https://clinicaltrials.gov/study/NCT03725059"},"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/nct03725059"}