Last updated on July 2020

Phase 2 Window Study of SAR439859 Versus Letrozole in ER+ HER2- Pre-operative Post-menopausal Primary Breast Cancer (AMEERA-4)

Brief description of study

Primary Objective:

To determine whether SAR439859 given at 2 different doses improves 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 50% (Ki6750%) 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 Study Description

Duration of the study, per patient, will include screening period of up to 14 days before randomization, treatment period of 14 days and post-treatment safety follow-up period of 307 days after last Investigational Medicinal Product (IMP) intake.

Clinical Study Identifier: NCT04191382

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Investigational Site Number 6430002

Saint -Petersburg, Russian Federation
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Investigational Site Number 6430003

Saint-Petersburg, Russian Federation
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Investigational Site Number 8400008

The Woodlands, TX United States
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Recruitment Status: Open

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