Clinical Trial

A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

Active, Not Recruiting Phase 2
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Record status
This record was last updated July 4, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.
Summary
The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer. Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2016-04-26; most recent amendment 2025-07-02.
Status change: Recruiting → Active, Not Recruiting 2023-06-23
Status change: Not Yet Recruiting → Recruiting 2016-08-02
Trial Details
NCT Number NCT02755272
Lead Sponsor Fox Chase Cancer Center
Collaborators: University of Wisconsin, Madison
Conditions Carcinoma Breast Stage IV
Enrollment 87 participants
Start Date 2016-05-31
Primary Completion 2026-05 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-07-04