Clinical Trial TitlePhase III trial to evaluate the efficacy & safety of MK-3475 (pembrolizumab) as adjuvant therapy for triple receptor-negative breast cancer with ≥ 1cm residual invasive cancer or positive lymph nodes (ypN+) after neoadjuvant chemotherapy.
National Clinical Trial Number:NCT02954874
Clinical Trial Protocol Description:
This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information below to join the study at one location.
This randomized phase III trial studies how well experimental drug MK-3475 (also called pembrolizumab) works in treating triple-negative breast cancer. The purpose of this study is to compare the usual approach (example: no more treatment additional post-operative chemotherapy), to any effects, good and/or bad, of pembrolizumab after surgery. This study will allow the researchers to know whether treatment with pembrolizumab is better, the same, or worse than the usual approach.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) with residual invasive breast cancer.
- Have had neoadjuvant chemotherapy followed by surgery.
- Have completed your final breast surgery (rendering you free from disease) prior to screening registration.
You will be excluded from the study if any of the following criteria apply to you:
- Have metastatic disease.
- Have had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs.
- Have active autoimmune disease that has required systemic treatment in past 2 years. (Replacement therapy is not considered a form of systemic treatment.)
This is a partial list of inclusion and exclusion criteria.