Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer

Official Title

A Randomized, Multicentre, 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


A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery)chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

Trial Description

Primary Outcome:

  • Pathological Complete response (pCR) Pathological Complete response (pCR) Using the definition of ypT0/is ypN0
  • Event-Free Survival (EFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Disease-free Survival (DFS)
  • Distant Metastasis-free survival (DMFS)
  • Pathological Complete Response (pCR) using the definition of ypT0 ypN0
  • Pathological Complete Response (pCR) rate using the definition of ypT0/is
  • Objective response rate (ORR) using definition of tumour response rate per radiologic-based assessment
  • Objective response rate (ORR) using definition of tumour response rate per clinic-based physical assessment
  • Residual cancer burden (RCB) category status (0, I, II, III)
  • Incidence of adverse events (AEs)
  • Severity of adverse events (AEs)
  • Change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life (QOL) subscale (items 29 and 30)
  • Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5)

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society