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Clinical trial · no report yet · Phase 3

KEYNOTE-756

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)

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Preliminary discovery

Commentary in our index that names this trial so far

Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.

ChannelFound
YouTube49
Podcasts45
X threads40

The trial

ClinicalTrials.gov
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)
Phase
Phase 3
Status
Active, not recruiting
Conditions
Breast Cancer
Interventions
Pembrolizumab (K); Placebo (P); Paclitaxel (X); Doxorubicin (A); Epirubicin (E); Cyclophosphamide (C); Endocrine therapy; Radiation therapy; Surgery
Arms
  • Pembrolizumab+Chemotherapy (KX/KA[E]C) · Experimental
  • Placebo+Chemotherapy (PX/PA[E]C) · Placebo comparator
Enrollment
1,240 (estimated)
Primary outcomes
  • Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0
  • Event-Free Survival (EFS)
Sponsor
Merck Sharp & Dohme LLC
Start
Dec 27, 2018
Primary completion
Jan 24, 2031 (estimated)
Results posted
No
Registry record
NCT03725059 · updated Jul 11, 2025

Publications

linked from the registry
  • 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. PubMed 39838117
  • 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. PubMed 38913933