Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Randomized, Multicenter, Double-blind, Phase 3 Study of Amcenestrant (SAR439859) Versus Tamoxifen for the Treatment of Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative or Positive, Stage IIB-III Breast Cancer Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
Study ID: NCT05128773
Conditions
Study Description
Brief Summary: This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity. The primary objective was to demonstrate the superiority of amcenestrant versus tamoxifen on invasive breast cancer-free survival. The treatment duration per participant was to be 5 years, followed with a subsequent 5-years follow-up period. For the treatment period, visits were 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 were scheduled 30 days after last treatment and then every 12 months. Three periods were 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.
Detailed Description: Study duration per participant was to be approximately 10 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Investigational Site Number :1521622, Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number :1561599, Haikou, , China
Contact Details
Name: Etienne Brain, MD PhD
Affiliation: Institut Curie (Saint-Cloud and Paris), 35 rue Dailly, 92210 Saint-Cloud
Role: STUDY_CHAIR
Name: David Cameron, Professor of Oncology
Affiliation: University of Edinburgh Cancer Centre, institute of Genetics and Cancer, Western General Hospital, Crewe Road South, EDINBURGH EH4 2XU Scotland
Role: STUDY_CHAIR
Name: Otto Metzger, MD
Affiliation: Dana-Farber Cancer Institute, 450 Brookline Avenue Yawkey 1250
Role: STUDY_CHAIR
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