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閉経後術前ER+、HER2-閉経後原発性乳がん患者を対象としたSAR439859(アムセネストラント)とレトロゾールを比較する第2相試験
基本情報
- NCT ID
- NCT04191382
- 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
- 105
- 治験依頼者名
- Sanofi
概要
Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole. Secondary Objectives: * To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested by immunohistochemistry greater than or equal to (\>=) 50 percent (%) (Ki67 \>=50%) in the three treatment arms. * To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms. * To assess safety in the three treatment arms.
対象疾患
Breast Cancer
介入
Amcenestrant (SAR439859)(DRUG)
Letrozole(DRUG)
依頼者(Sponsor)
サノフィ株式会社(INDUSTRY)