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

NCT02273973 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2018-05-21

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • SOLTI Breast Cancer Research Group

    collaborator OTHER

  • Breast International Group

    collaborator OTHER

  • Austrian Breast and Colorectal Cancer Group

    collaborator UNKNOWN

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-12
Primary Completion
2017-03-13
Completion
2017-03-13

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02273973 on ClinicalTrials.gov