A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)
The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in
combination with one of three different chemotherapies will be assessed in the treatment of
locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has
not been previously treated with chemotherapy. In Part 2, the safety and efficacy of
pembrolizumab plus chemotherapy will be assessed compared to the safety and efficacy of
placebo plus chemotherapy in the treatment of locally recurrent inoperable or metastatic
TNBC, which has not been previously treated with chemotherapy.
The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs
Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and
in participants with programmed cell death ligand 1 (PD-L1) positive tumours, and prolongs
Overall Survival (OS) compared to placebo and chemotherapy in all participants and in
participants with PD-L1 positive tumours.
View this trial on ClinicalTrials.gov
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