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Neoadjuvant letrozole plus taselisib vs letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): A multicentre, randomized, double-blind, placebo-controlled, phase 2 trial

The Lancet Oncology Aug 14, 2019

Saura C, Hlauschek D, Oliveira M, et al. - In the LORELEI trial, researchers examined if combination therapy with taselisib and letrozole could increase the amount of objective responses and pathological complete responses in postmenopausal women (aged ≥ 18 years) with estrogen receptor (ER)-positive, HER2-negative, stage I–III operable breast cancer. From 85 hospitals in 22 countries worldwide, 334 patients with an Eastern Cooperative Oncology Group performance status 0–1, adequate organ function, and tumor tissue that could be evaluated for PIK3CA genotyping were enrolled. Randomization of patients to receive letrozole and placebo (n = 168) or letrozole and taselisib (n = 166) was done. As per outcomes, the addition of taselisib to endocrine therapy led to an increase in the proportion of patients who achieved an objective response in a neoadjuvant setting. This effect was consistent with the clinical benefit noted in hormone receptor-positive, HER2-negative, metastatic breast cancer.

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