Keynote 355 plus#

Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.

Triple Negative Breast Cancer (TNBC) Programmed Cell Death-1 (PD1, PD-1) Programmed Cell Death 1 Ligand 1(PDL1, PD-L1) Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2) Breast Neoplasms Triple Negative Breast Neoplasms Gemcitabine Paclitaxel Albumin-Bound Paclitaxel Carboplatin Pembrolizumab Nab-paclitaxel Normale Saline Solution

Keynote 355 plus#

Official TitleĪ 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) Keywords the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in: - all participants, - participants with PD-L1 CPS ≥1 tumors, and - participants with PD-L1 CPS ≥10 tumors. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in: - all participants, - participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and - participants with PD-L1 CPS ≥10 tumors, and 2. In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy. 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.