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Clinical Trials

Topic   Cancer - Breast Cancer
Title   S1418/BR006: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with = 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvan
Summary   The aim of the study is compare the usual approach, standard of care, to any effects, good or bad, of the experimental drug MK-3475 (Pembrolizumab) after neoadjuvant chemotherapy followed by breast cancer surgery. Standard of care is no additional treatment or possibly additional chemotherapy. This study will allow researchers to know whether treatment with MK-3475 (Pembrolizumab) is better, the same, or worse than the usual approach. The relationship between biomarkers of inflammation and quality of life will be examined.
Description   Patients will be randomized to one of two possible groups. Patients will receive be observed and monitored, which is standard of care, or will receive MK-3475 (Pembrolizumab) intravenously every 3 weeks for 52 weeks. All patients will be followed for 10 years to assess the effects of Pembrolizumab compared to observation.
IRB Number   10106263
Inclusion/Notes   To be eligible to participate in this study, patients must meet several criteria, including but not limited to the following: 18 years of age or older; triple negative breast cancer with residual invasive breast cancer after neoadjuvant chemotherapy and surgery; positive lymph nodes observed on pathologic exam; if lymph nodes are not positive, residual invasive disease must be = 1 cm; no metastatic disease.
Status   Open
Start Date   02/02/2017
Principal Name   Nina D’Abreo, MD
Contact Name   Johanna Lee, RN
Fax   516-663-1871
Current Trial Type   Interventional
Phone   516-663-1237
Alternate Phone   516-663-8391