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

Updated: 9 September, 2020   |   ClinicalTrials.gov

Print Friendly Summary

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


  • Gender(s)

  • 18+

    Age Range

  • 15


  • Recruiting

Treatment Options

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

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
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