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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: 14 May, 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 Drug: nivolumab
Experimental: Group A Target Class A-2: nivolumab+nab-paclitaxel+ipilimumab
Drug: nab-paclitaxel Drug: ipilimumab Drug: nivolumab
Experimental: Group A Target Class A-3: nivolumab+nab-paclitaxel+ipilimumab
Drug: nivolumab Drug: nab-paclitaxel Drug: 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 positive status - ER negativity defined as < 1% of tumor cells expressing hormonal receptors via IHC analysis - Metastatic disease or locoregionally recurrent disease in participants that have had 1 - 3 prior regimens for the treatment of metastatic disease, including endocrine therapy or chemotherapy - At least one measureable lesion, as per Response Evaluation Criteria in Solid Tumors version 1.1 (Recist 1.1) - Sufficient tumor tissue (>_ 20mm^3) obtained from metastatic or locoregionally recurrent tumor lesions during the screening period prior to first study dose - ECOG performance of 0 or 1 - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test and not be breastfeeding Exclusion Criteria: - Any significant acute or chronic medical disease including autoimmune diseases, type I diabetes mellitus, hyperthyroidism, chronic hepatitis, or skin disorders - HER2-positive status or a negative/unknown ER status - Allergy or hypersensitivity to any study drugs or their excipients - Any major surgery within 4 weeks of study drug administration - History of unstable or deteriorating cardiac disease, myocardial infarction or stroke - Any other sound medical, psychiatric and/or social reason as determined by the investigator - Prior therapy with anit-PD-1, anti-PD-L1 or anti-CTLA-4 antibody - Participants with a condition requiring systemic treatment or other immunosuppressive medications - Evidence of organ dysfunction or any clinically significant deviation from normal - Positive urine screen for drugs of abuse - Positive blood screen for HIV-1 and -2 antibody Other protocol defined inclusion/exclusion criteria could 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

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com