生殖細胞系列BRCA 1/2変異トリプルネガティブ乳がんに対する新たな術前・術後補助療法戦略

基本情報

NCT ID: NCT05485766
ステータス: 募集中
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 23
治験依頼者名: Okayama University

概要

This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1/2 mutated triple negative breast cancer (TNBC). Pembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied

対象疾患

Breast CancerTriple Negative Breast NeoplasmsTriple Negative Breast CancerBreast NeoplasmsBRCA1 MutationBRCA2 MutationBRCA MutationBRCA-Associated Breast Carcinoma

介入

Pembrolizumab(DRUG)

Paclitaxel(DRUG)

Carboplatin(DRUG)

Olaparib(DRUG)

Definitive Surgery(PROCEDURE)

依頼者（Sponsor）

MSD株式会社(INDUSTRY)

Okayama University(OTHER)

実施施設 (3)

聖路加国際病院

Tokyo, Japan(RECRUITING)

岡山大学病院

Okayama, Japan(RECRUITING)

岐阜大学医学部附属病院

Gifu, Gifu, Japan(RECRUITING)