🏥 治験ポータル
← 治験一覧に戻る

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)