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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: 05 Feb 2024

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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

    • 09 Dec 2023 Results assessing primary pCR results and residual cancer burden (RCB) outcomes presented at the 46th Annual San Antonio Breast Cancer Symposium.
    • 24 Oct 2023 Interim Results (at data cut off May 25, 2023) assessing efficacy of neoadjuvant pembrolizumab or placebo + chemotherapy, followed by adjuvant pembro or pbo + endocrine therapy for early-stage high-risk ER+/HER2 negative breast cancerpresented at the 48th European Society for Medical Oncology Congress
    • 20 Oct 2023 According to a Merck media release, data from this trial presented at the European Society for Medical Oncology (ESMO) Congress 2023
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