局所進行性または転移性ER陽性乳がんにおけるアムセネストラント（SAR439859）と医師の選択による治療との比較に関する第2相試験
基本情報
- NCT ID
- NCT04059484
- ステータス
- 中止
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 367
- 治験依頼者名
- Sanofi
概要
Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: * To compare the overall survival in the 2 treatment arms * To assess the objective response rate in the 2 treatment arms * To evaluate the disease control rate in the 2 treatment arms * To evaluate the clinical benefit rate in the 2 treatment arms * To evaluate the duration of response in the 2 treatment arms * To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms * To evaluate the pharmacokinetics of amcenestrant as single agent * To evaluate health-related quality of life in the 2 treatment arms * To compare the overall safety profile in the 2 treatment arms