Immunotherapy Combinations for Triple-Negative Breast Cancer
Immunotherapy combination trial for triple-negative breast cancer. Phase II study testing novel immune-activating agents with pembrolizumab.
Phase II Randomized Trial of Immunotherapy Combinations in Triple-Negative Breast Cancer
Full Title
A randomized, open-label, phase II study comparing pembrolizumab plus novel immune-activating agents versus pembrolizumab alone in patients with metastatic triple-negative breast cancer
Purpose
Triple-negative breast cancer is harder to treat because it lacks targets for hormone therapy or HER2 drugs. This study tests whether combining different immunotherapy drugs works better than using immunotherapy alone to help your immune system fight this aggressive type of breast cancer.
Primary Objectives
- Compare progression-free survival between combination immunotherapy and pembrolizumab monotherapy
- Evaluate overall response rate and duration of response
- Assess safety and tolerability of novel immunotherapy combinations
Diseases
- Breast Cancer
- Triple-Negative Breast Cancer
- Metastatic Breast Cancer
Who Can Join this Trial
To participate in this study, you must meet ALL of the following criteria
- Have histologically confirmed metastatic triple-negative breast cancer
- Have received no more than two prior lines of chemotherapy for metastatic disease
- Tumor must express PD-L1 with combined positive score ≥1
- Have at least one measurable lesion per RECIST v1.1 criteria
- ECOG performance status 0-1
- Age 18 years or older
- Life expectancy ≥12 weeks
- Adequate organ function including blood counts, heart, liver, and kidney function
- No active brain metastases
- No active autoimmune disease requiring systemic treatment
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