A Phase III, Randomized, Double-blind Study to Evaluate Chemotherapy plus Pembrolizumab vs Chemotherapy plus Placebo as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple ...

Update Il y a 4 ans
Reference: EUCTR2016-004740-11

A Phase III, Randomized, Double-blind Study to Evaluate Chemotherapy plus Pembrolizumab vs Chemotherapy plus Placebo as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

Woman and Man

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Extract

1. To evaluate the rate of pCR using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) as assessed by the local pathologist at the time of definitive surgery in subjects with locally advanced TNBC 2.To evaluate the event-free survival (EFS) as assessed by Investigator in subjects with locally advanced TNBC during the Neoadjuvant and Adjuvant Treatment Phases.


Inclusion criteria

  • Neoadjuvant and adjuvant treatment for locally-advanced TNBC