Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 105
- 试验地点
- 32
- 主要终点
- Percent Change From Baseline in Ki67 Level at Day 15
研究概览
简要总结
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.
详细描述
Duration of the study, per participant, would include screening period of up to 14 days before randomization, treatment period of 14 days and post-treatment safety follow-up period of 30±7 days after last investigational medicinal product (IMP) intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Amcenestrant 400 mg
Participants received 4 capsules of 100 milligrams (mg) of amcenestrant once daily (QD) from Day 1 to Day 14.
干预措施: Amcenestrant (SAR439859) (Drug)
Amcenestrant 200 mg
Participants received 2 capsules of 100 mg of amcenestrant QD from Day 1 to Day 14.
干预措施: Amcenestrant (SAR439859) (Drug)
Letrozole 2.5 mg
Participants received 2.5 mg of letrozole tablet QD from Day 1 to Day 14.
干预措施: Letrozole (Drug)
结局指标
主要结局
Percent Change From Baseline in Ki67 Level at Day 15
时间窗: Baseline, Day 15
Tumor tissue collected through a core-cut biopsy at Baseline and Day 15 was used to determine Ki67 expression. Ki67 expression was defined as the percentage of positive tumor cells assessed by central reading. Ki67 percent change from Baseline for a given participant was defined as 100\*(Ki67pre - Ki67post) / Ki67pre, where Ki67pre and Ki67post were pre-treatment and post-treatment Ki67 value of the participant. Adjusted geometric least square (LS) means and 95 percentage (%) confidence interval (CI) for the percent change were obtained from analysis of covariance (ANCOVA) model of the log proportional change i.e., log (Ki67post/ki67pre) with treatment and log-Ki67pre as fixed effect and converted by antilog transformation.
次要结局
- Number of Participants With Abnormalities: Hematological Parameters(From first dose of study drug up to Day 14)
- Percentage of Participants With Percent Change From Baseline in Ki67 Greater Than or Equal to (>=) 50 Percent at Day 15(Baseline, Day 15)
- Change From Baseline in Estrogen Receptor (ER) Expression as Measured by H-Score at Day 15(Baseline, Day 15)
- Number of Participants With Abnormalities: Clinical Chemistry(From first dose of study drug up to Day 14)