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Not Yet Recruiting

Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer - CA209-7FL

Updated: 27 September, 2019   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 68

    Location(s)

  • Not Yet Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
Drug: Endocrine Therapy Procedure: Surgery Drug: anthracycline Biological: nivolumab Drug: paclitaxel (PTX) Drug: cyclophosphamide
Placebo Comparator: Arm B: Placebo combined with neoadjuvant CT and adjuvant ET
Drug: paclitaxel (PTX) Other: nivolumab placebo Procedure: Surgery Drug: cyclophosphamide Drug: Endocrine Therapy Drug: anthracycline

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Participant has untreated, unilateral invasive, histologically confirmed, localized invasive breast ductal carcinoma that includes either T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is allowed. - Participant has centrally confirmed ER+ invasive breast cancer with or without progesterone receptor expression, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines. - Participant must agree to provide tumor tissue at baseline and at surgery. - Participant must be deemed eligible for neoadjuvant chemotherapy. - Participant must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy. - Women and men must agree to follow instructions for methods of contraception. - Participant must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1. Exclusion Criteria: - Participant who is breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment. - Prior treatment with chemotherapy, endocrine therapy, targeted therapy, and/or radiation administered for the currently diagnosed breast cancer, or where upfront chemotherapy is judged clinically inappropriate as optimal neoadjuvant treatment. - Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways, or history of allergy, or hypersensitivity to study medication. - Participant has significant cardiovascular disease such as left ventricular ejection fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association. Other inclusion/exclusion criteria may apply.

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