CA209-7FL

About this trial

The purpose of this study is to evaluate 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.

Patient Profile

Patients with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer

Where’s this trial being run?

Beaumont Hospital, Cork University Hospital, and St James’s Hospital

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

Why not Print this page and bring it with you. It will help your doctor and research team advise you.

For more detailed information

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.


Summary Data

Name: CA209-7FL
Number: 19-35
Full Title:

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

Principal Investigator: Prof Patrick Morris (Beaumont Hospital)
Type: Industry Sponsored
Sponsor:

Bristol-Myers Squibb

Recruitment Started: Global: Nov-19
Ireland: Dec-20
Global Recruitment Target: 1200
Ireland Recruitment Target: