Status:
COMPLETED
A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
September 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04132817
Start Date
September 22 2020
End Date
August 15 2022
Last Update
December 2 2022
Active Locations (8)
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1
Local Institution
Los Angeles, California, United States, 90033
2
Local Institution - 0003
Sacramento, California, United States, 95817
3
Local Institution - 0009
Aurora, Colorado, United States, 80045
4
Local Institution - 0002
St Louis, Missouri, United States, 63110