AMEERA-4: a randomized, preoperative window-of-opportunity study of amcenestrant versus letrozole in early breast cancer.

ABSTRACT:

Background

Window-of-opportunity (WOO) studies provide insights into the clinical activity of new drugs in breast cancer.

Methods

AMEERA-4 (NCT04191382) was a WOO study undertaken to compare the pharmacodynamic effects of amcenestrant, a selective estrogen receptor degrader, with those of letrozole in postmenopausal women with newly diagnosed, operable estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. Women were randomized (1:1:1) to receive amcenestrant 400 mg, amcenestrant 200 mg, or letrozole 2.5 mg once daily for 14 days before breast surgery. The primary endpoint was change in Ki67 between baseline and Day 15 (i.e., day of surgery).

Results

Enrollment was stopped early because of slow recruitment, in the cont

SUBMITTER: Campone M 

PROVIDER: S-EPMC10638815 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature