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A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

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Trial Profile

A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs Nivolumab (Primary) ; Anastrozole; Anthracyclines; Cyclophosphamide; Doxorubicin; Epirubicin; Exemestane; Letrozole; Paclitaxel; Tamoxifen
  • Indications Ductal carcinoma; Early breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CheckMate 7FL
  • Sponsors Bristol-Myers Squibb

Most Recent Events

  • 01 Feb 2025 Results(From 20 November 2019 to 7 April 2022, N=830) hypothesizing that addition of an anti-programmed death 1 agent may increase pCR rates in this BC subtype , published in the Nature Medicine
  • 28 Mar 2024 This study has been completed in Portugal, according to European Clinical Trial Database record.
  • 08 Mar 2024 This study has been completed in Belgium, according to European Clinical Trial Database record.

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