トリプルネガティブ乳がん（TNBC）患者を対象とした、術前化学療法としてのペムブロリズマブ（MK-3475）と化学療法の併用とプラセボと化学療法の併用、および術後化学療法としてのペムブロリズマブとプラセボの併用を比較する試験（MK-3475-522/KEYNOTE-522）

基本情報

NCT ID

NCT03036488

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,174

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC). After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence. The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.

対象疾患

介入

依頼者（Sponsor）

実施施設 (18)