A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
- Conditions
- Carcinoma Breast Stage IV
- Interventions
- Registration Number
- NCT02755272
- Lead Sponsor
- Fox Chase Cancer Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab with Standard Chemotherapy Gemcitabine Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine. Pembrolizumab with Standard Chemotherapy Carboplatin Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine. Pembrolizumab with Standard Chemotherapy Pembrolizumab Pembrolizumab plus standard chemotherapy using carboplatin and gemcitabine. Standard Chemotherapy Alone Carboplatin Standard chemotherapy alone using carboplatin and gemcitabine. Standard Chemotherapy Alone Gemcitabine Standard chemotherapy alone using carboplatin and gemcitabine.
- Primary Outcome Measures
Name Time Method Objective Response Rate Up to 24 months Evaluate antitumor activity by assessing the percentage of patients with evidence of complete response or partial response per RECIST 1.1 criteria.
Incidence of Treatment-Related Adverse Events From the first dose of study treatment until 30 days after discontinuation of study treatment. The safety and tolerability of Pembrolizumab in Combination with Carboplatin and Gemcitabine will be evaluated from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results.
- Secondary Outcome Measures
Name Time Method Progression Free Survival From the start of treatment until progressive disease or date of death, whichever occurs first (assessed up to 60 months.) Evaluate antitumor activity by assessing the time interval from initiation of study drug until progressive disease or death whichever occurs first.
Overall Survival From the start of treatment until death (assessed up to 60 months.) Evaluation of the overall survival rate of patients
Clinical Benefit Rate Up to 24 months Evaluate antitumor activity by assessing the percentage of patients with evidence of complete response, partial response, or stable disease per RECIST 1.1 criteria
Trial Locations
- Locations (6)
Indiana University
🇺🇸Indianapolis, Indiana, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States