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Amcenestrant · AMEERA-6

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

Ensayo de Sanofi en Cancer de mama.

Más ensayos de: Cáncer de mama.

Fase

Fase 3

Estado

Interrumpido

Participantes

3

previstos

Centros

2

Fin del objetivo primario

oct 2022

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2022.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Sponsor decision to prematurely stop the study, not linked to any safety concern».

Qué mide

Invasive Breast Cancer-free Survival (IBCFS) (From randomization to the date of first occurrence of IBCFS event (maximum exposure duration: 155 days)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05128773), actualizada en sep 2025.