CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 334 enrolled
Drug / intervention
Letrozole +2 moredrug
Likely dose
Letrozole 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02273973
NCT02273973Phase 2Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Oct 24, 2014·Updated May 21, 2018

In Brief

A Phase 2 clinical trial evaluating Letrozole, Placebo, and 1 other intervention for Breast Cancer. Completed, enrolled 334 participants across 117 sites in 22 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Brazil, Chile, Czechia, El Salvador, France, Germany, Guatemala, Hungary, Italy, Mexico, Panama, Peru, Poland, Portugal, South Korea, Spain, Switzerland, United Kingdom, United States
CollaboratorsSOLTI Breast Cancer Research Group, Breast International Group, Austrian Breast & Colorectal Cancer Study Group

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 24, 2014
Enrollment StartNov 12, 2014
Primary CompletionMar 13, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.7 years ago

Interventions

Letrozoledrug

Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks.

Placeboother

Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks.

Taselisibdrug

Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily.