At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed breast adenocarcinoma
- ✓Triple-negative: ER ≤10%, PR ≤10%, HER2 negative (IHC 0-2+ without amplification or ISH negative)
- ✓Phase II: ≤3 prior lines of therapy in metastatic setting; Phase I: no limit on prior therapy
- ✓Measurable disease by RECIST 1.1
- ✕Pregnant or nursing women; men/women of childbearing potential unwilling to use adequate contraception
- ✕Immunocompromised or receiving systemic steroids/immunosuppressive therapy within 7 days (inhaled steroids and low-dose corticosteroids allowed)
- ✕Active tuberculosis, HIV, active hepatitis B or C
- ✕Prior anti-cancer monoclonal antibody within 4 weeks or failure to recover to ≤grade 1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of Pembrolizumab in Combination With Binimetinib in Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Binimetinib, Laboratory Biomarker Analysis, and 1 other intervention for Breast Adenocarcinoma and 6 related conditions. Completed, enrolled 23 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Given PO
Correlative studies
Given IV