OncRef

Clinical Trial: NCT02273973

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Genentech, Inc.
Information Provided By:Genentech, Inc.
Last Update Posted:2018-05-21

Study Overview

Brief 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.

Official Title

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

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Letrozole
  • Other: Placebo
  • Drug: Taselisib

Other Study ID Numbers

  • GO28888
  • 2013-000568-28

Start Date (Actual)

2014-11-12

Primary Completion Date (Actual)

2017-03-13

Study Completion Date (Actual)

2017-03-13

Enrollment (Actual)

334

Study Type

Interventional

Phase

Phase 2