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A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with 1 cm Residual Invasive Cancer or Positive Lymph Nodes (pN1mic) After Neoadjuvant Chemotherapy
Study of Experimental Drug for Triple Receptor-Negative Breast Cancer
| Sponsor: | NCI SWOG |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAR1909 |
| U.S. Govt. ID: | NCT02954874 |
| Contact: | Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
Additional Study Information:
The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse than the usual approach. There will be about 1,000 people taking part in this study.
This study is closed
Do You Qualify?
| Have you been diagnosed with triple-negaive breast cancer with residual invasive breast cancer after neoadjuvant chemotherapy? | Yes | No |
| Do you have metastatic disease? | Yes | No |
| Have you had neoadjuvant chemotherapy followed by surgery? | Yes | No |
| Have you had prior immunotherapy with anti-PD-L1, anti-PD-1, anti-CTLA4 or similar drugs? | Yes | No |