Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

Summary

Primary 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

Timeline

Start

2019-10-22

Primary completion

2022-02-15

Completion

2025-01-02

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision to prematurely stop the study, not linked to any safety concern.”

paper AMEERA-3 did not meet its primary objective of improved PFS with amcenestrant versus TPC PMID 37348019 ↗

registry p = 0.6437; Hazard Ratio (HR) 1.051 (95% CI 0.789 to 1.4) NCT04059484 ↗

release “The Phase 2 AMEERA-3 clinical trial evaluating amcenestrant, an investigational optimized oral selective estrogen receptor degrader (SERD), did not meet its primary endpoint” sanofi.com ↗

Publications

• Results Tolaney SM, Chan A, Petrakova K, Delaloge S, Campone M, Iwata H, Peddi PF, Kaufman PA, De Kermadec E, Liu Q, Cohen P, Paux G, Wang L, Ternes N, Boitier E, Im SA. AMEERA-3: Randomized Phase II Study of Amcenestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Monotherapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer. J Clin Oncol. 2023 Aug 20;41(24):4014-4024. doi: 10.1200/JCO.22.02746. Epub 2023 Jun 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amcenestrant	Other / unclassified	—	Oral
Comparator	Anastrozole	Other / unclassified	—	Oral
Comparator	Exemestane	Small molecule	—	Oral
Comparator	Fulvestrant	Small molecule	—	Intramuscular
Comparator	Letrozole	Other / unclassified	—	Oral
Comparator	Tamoxifen	Small molecule	—	Oral

Indications