Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity

• Status: Not yet recruiting
• Trial end date: 2033-12-27

Summary

This is a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in patients with hormone receptor-positive early breast cancer who have discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity. The primary objective is to demonstrate the superiority of amcenestrant versus tamoxifen on invasive breast cancer-free survival.

The treatment duration per participant will be 5 years, followed with a subsequent 5-years follow-up period. For the treatment period, visits are scheduled at the start of treatment, then at 4 weeks and 12 weeks after treatment start, and then every 12 weeks for the first 2 years and every 24 weeks for year 3 to 5. For the follow-up period, visits are scheduled 30 days after last treatment and then every 12 months. Three periods are planned:

• A screening period of up to 28 days,

• A treatment period of up to 5 years,

• A follow-up period of up to 5 years.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Collaborators: Alliance for Clinical Trials in Oncology; Breast International Group; European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Tamoxifen