NCT04191382

Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Amcenestrant (SAR439859)	Pharmaceutical form: Capsules, Route of administration: Oral
DRUG	Letrozole	Pharmaceutical form: Tablets, Route of administration: Oral

Timeline

• Start date: 2020-02-04
• Primary completion: 2021-04-30
• Completion: 2021-05-28
• First posted: 2019-12-09
• Last updated: 2025-09-18
• Results posted: 2022-06-29

Locations

32 sites across 9 countries: United States, Belgium, France, Italy, Japan, Puerto Rico, Russia, Spain, Ukraine

Regulatory

• FDA-regulated drug study