A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

Locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1

Overall Survival (OS) in Participants With CPS ≥ 1, PFS per RECIST 1.1 by BICR in Participants With CPS ≥10, Overall Survival (OS) in Participants With CPS ≥ 10, PFS per RECIST 1.1 by Investigator in Participants With CPS ≥10, PFS per RECIST 1.1 by Investigator in Participants With CPS ≥1, Objective Response Rate (ORR) per RECIST 1.1 by BICR in Participants With CPS ≥10, ORR per RECIST 1.1 by BICR in Participants With CPS ≥1, Disease Control Rate (DCR) per RECIST 1.1 by BICR in Participants With CPS ≥10, DCR per RECIST 1.1 by BICR in Participants With CPS ≥1, Duration of Response (DOR) per RECIST 1.1 by BICR in Participants With CPS ≥10, DOR per RECIST 1.1 by BICR in Participants With CPS ≥1, Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10, Change From Baseline in Global Health Status/Quality of Life Score on the EORTC QLQ-C30 in Participants with CPS ≥1, Change From Baseline in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10, Change From Baseline in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1, Change From Baseline in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10, Change From Baseline in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1, Change From Baseline in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥10, Change From Baseline in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥1, Change From Baseline in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥10, Change From Baseline in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥1, Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the EORTC QLQ-C30 in Participants with CPS ≥10, TTD in Global Health Status/Quality of Life Score on the EORTC QLQ-C30 in Participants with CPS ≥1, TTD in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10, TTD in Physical Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1, TTD in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥10, TTD in Emotional Functioning Score on the EORTC QLQ-C30 in Participants with CPS ≥1, TTD in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥10, TTD in Fatigue Score on the EORTC QLQ-C30 in Participants with CPS ≥1, TTD in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥10, TTD in Diarrhea Score on the EORTC QLQ-C30 in Participants with CPS ≥1, Percentage of Participants who Experience an Adverse Event (AE), Percentage of Participants who Discontinue Study Drug due to an AE

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