Letrozole-matching placebo

DRUG2 trials

Sponsors

Sanofi, Olema Pharmaceuticals, Inc.

Conditions

Breast CancerER Positive Breast CancerHER2 Negative Breast CarcinomaLocally Advanced Breast CancerMetastatic Breast Cancer

Phase 3

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

TerminatedNCT04478266

SanofiBreast Cancer

Start: 2020-10-14End: 2023-05-26Updated: 2025-09-11

Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

RecruitingNCT07085767

Olema Pharmaceuticals, Inc.Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma +2

Start: 2025-11-03End: 2032-01-01Target: 1000Updated: 2026-03-16

Related Papers

Randomized Phase III Study of Amcenestrant Plus Palbociclib Versus Letrozole Plus Palbociclib in Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Primary Results From AMEERA-5

Journal of Clinical Oncology2024-06-1813 citations

Optimizing Early-stage Clinical Pharmacology Evaluation to Accelerate Clinical Development of Giredestrant in Advanced Breast Cancer

Cancer Research Communications2023-11-295 citations

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

Journal of Clinical Oncology2023-06-2267 citations

AMEERA-1 phase 1/2 study of amcenestrant, SAR439859, in postmenopausal women with ER-positive/HER2-negative advanced breast cancer

Nature Communications2022-07-1551 citations

Abstract OT2-11-08: AMEERA-5 : A randomized, double-blind phase 3 study of amcenestrant (SAR439859) + palbociclib versus letrozole + palbociclib for previously untreated ER+/HER2- advanced breast cancer

Cancer Research2022-02-15

AMEERA-5: a randomized, double-blind phase 3 study of amcenestrant plus palbociclib <i>versus</i> letrozole plus palbociclib for previously untreated ER+/HER2– advanced breast cancer

Therapeutic Advances in Medical Oncology2022-01-0128 citations

AMEERA-5: A randomized, double-blind phase III study of amcenestrant (SAR439859) + palbociclib versus letrozole + palbociclib for previously untreated ER+/HER2- advanced breast cancer.

Journal of Clinical Oncology2021-05-202 citations