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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)

Trial Profile

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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Jun 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Cyclophosphamide; Doxorubicin; Epirubicin; Paclitaxel
  • Indications Adenocarcinoma; Early breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-756
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 01 Feb 2025 Results(From 27 December 2018 to 5 August 2022, n=1278,data cutoff, 25 May 2023) discussing significance of addition of pembrolizumab to neoadjuvant chemotherapy with respect to pathological complete response rate in patients with high-risk, early-stage ER+/HER2 breast cancer, published in the Nature Medicine
  • 22 Mar 2024 Results of primary pCR results and residual cancer burden (RCB) outcomes, presented at the 14th European Breast Cancer Conference
  • 09 Dec 2023 Results assessing primary pCR results and residual cancer burden (RCB) outcomes presented at the 46th Annual San Antonio Breast Cancer Symposium.

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