Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT03106415 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2025-06-27
Summary
This phase I/II trial studies the best dose of pembrolizumab and binimetinib and how well it works when given together with pembrolizumab in treating patients with triple negative breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and binimetinib may work better in treating patients with triple negative breast cancer.
Conditions
- Breast Adenocarcinoma
- Metastatic Triple-Negative Breast Carcinoma
- Stage III Breast Cancer AJCC v7
- Stage IIIA Breast Cancer AJCC v7
- Stage IIIB Breast Cancer AJCC v7
- Stage IIIC Breast Cancer AJCC v7
- Stage IV Breast Cancer AJCC v6 and v7
Interventions
- DRUG
-
Binimetinib
Given PO
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Saranya Chumsri, M.D. · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-27
- Primary Completion
- 2022-05-19
- Completion
- 2022-05-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
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