Breast Cancer Clinical Trial
A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread
Summary
The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.
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
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There are 8 Locations for this study
Los Angeles California, 90033, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75390, United States
San Antonio Texas, 78229, United States
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