未治療の局所進行性または転移性トリプルネガティブ乳がん（TNBC）患者を対象とした、アテゾリズマブとパクリタキセルの併用療法とプラセボとパクリタキセルの併用療法を比較した研究

基本情報

NCT ID

NCT03125902

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

653

治験依頼者名

Hoffmann-La Roche

概要

This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \[PD-L1\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

対象疾患

介入

依頼者（Sponsor）

実施施設 (10)