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Fox Chase BR-076: Pembrolizumab for Triple Negative Metastatic Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study is to see if the study drug, pembrolizumab, plus chemotherapy (carboplatin and gemcitabine) is safe and effective in treating people with metastatic triple negative breast cancer.

What is the Condition Being Studied?

Triple Negative Metastatic Breast Cancer

Who Can Participate in the Study?

Adult women who :
- Have metastatic, triple negative breast cancer (spread to other parts of your body).
- Have already received up to 2 cancer therapies for their metastatic breast cancer
- Are candidates for chemotherapy with carboplatin and gemcitabine.

Age Group
Adults

What is Involved?

If you join this study, you will be randomly put into a study group, like drawing numbers out of a hat.

- If you are in group 1, you will get pembrolizumab along with chemotherapy (carboplatin and gemcitabine).
- If you are in group 2, you will receive chemotherapy (carboplatin and gemcitabine) alone.

- You will have tests, exams, and procedures that are part of your standard of care and for study purposes.
- You will be asked to take the study drugs for up to 2 years. You will be followed until the study ends.

Study Details

Full Title
A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00086335
NCT:NCT02755272
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698