Calendario›SNY›Amcenestrant · AMEERA-3
Amcenestrant · AMEERA-3
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
Ensayo de Sanofi en Breast Cancer Metastatic (del registro, en inglés).
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 367
- Centros
- 109
- Fin del objetivo primario
- feb 2022
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, simple ciego. Comenzó en oct 2019.
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
Progression Free Survival (PFS) (From randomization to the date of first documented tumor progression or death due to any cause or data cut-off date whichever comes first (maximum duration: 116 weeks)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: * To compare the overall survival in the 2 treatment arms * To assess the objective response rate in the 2 treatment arms * To evaluate the disease control rate in the 2 treatment arms * To evaluate the clinical benefit rate in the 2 treatment arms * To evaluate the duration of response in the 2 treatment arms * To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms * To evaluate the pharmacokinetics of amcenestrant as single agent * To evaluate health-related quality of life in the 2 treatment arms * To compare the overall safety profile in the 2 treatment arms
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04059484), actualizada en feb 2026.