早期エストロゲン受容体陽性、ヒト上皮成長因子受容体2陰性（ER+/HER2-）乳がんに対するペムブロリズマブ（MK-3475）と術前化学療法および術後内分泌療法の併用療法におけるプラセボとの比較試験（MK-3475-756/KEYNOTE-756）

基本情報

NCT ID

NCT03725059

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

1,240

治験依頼者名

Merck Sharp & Dohme LLC

概要

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.

対象疾患

介入

依頼者（Sponsor）

実施施設 (16)