NCT02273973

A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)

A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks.
OTHER	Placebo	Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks.
DRUG	Taselisib	Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily.

Timeline

• Start date: 2014-11-12
• Primary completion: 2017-03-13
• Completion: 2017-03-13
• First posted: 2014-10-24
• Last updated: 2018-05-21
• Results posted: 2018-05-21

Locations

117 sites across 22 countries: United States, Australia, Austria, Belgium, Brazil, Chile, Czechia, El Salvador, France, Germany, Guatemala, Hungary, Italy, Mexico, Panama, Peru, Poland, Portugal, South Korea, Spain, Switzerland, United Kingdom