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Recruiting

A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread - CA048-001

Updated: 12 May, 2021   |   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 1

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 12

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Group A Target class A-1: Nivolumab+nab-paclitaxel
Biological: Nivolumab Drug: Nab-paclitaxel
Experimental: Group A Target Class A-2: Nivolumab+nab-paclitaxel+ipilimumab
Biological: Nivolumab Drug: Nab-paclitaxel Biological: Ipilimumab
Experimental: Group A Target Class A-3: Nivolumab+nab-paclitaxel+ipilimumab
Drug: Nab-paclitaxel Biological: Nivolumab Biological: Ipilimumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histological and cytological confirmation of adenocarcinoma of the breast - Documented HER2 negative and estrogen receptor (ER) positive status of primary or metastatic tumor tissue using the most recently assessed tumor specimen, according to the local laboratory parameters - ER negativity is defined as < 1% of tumor cells expressing hormonal receptors via IHC analysis - At least one measurable lesion, as per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT) or magnetic resonance imaging (MRI) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Women and Men must agree to follow specific methods of contraception, if applicable, while participating in the trial Exclusion Criteria: - Allergy or hypersensitivity to any study drugs or their excipients - Any other sound medical, psychiatric and/or social reason as determined by the investigator - Active, known, or suspected autoimmune disease or immune-related diseases - History of unstable or deteriorating cardiac disease within the previous 12 months prior to screening - Prior therapy with anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) or anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) class antibody - Any major surgery within 4 weeks of the first dose of study treatment Other protocol-defined inclusion/exclusion criteria apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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