CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,286 enrolled
Drug / intervention
Lapatinib +2 moredrug
Likely dose
Lapatinib 1500 mg orally once daily plus letrozole 2.5 mg orally once dailyAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed invasive breast cancer with stage IV disease (at primary diagnosis or relapse)
  • ✓ER+ and/or PgR+ tumors
  • ✓Postmenopausal female, age ≥18 years
  • ✓ECOG Performance Status 0 or 1
Key exclusion· 5
  • ✕Pre-menopausal, pregnant, or lactating status
  • ✕Prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease
  • ✕CNS metastases or leptomeningeal carcinomatosis
  • ✕Investigational drug use within 30 days or 5 half-lives (whichever longer) before randomization

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

Search/NCT00073528
NCT00073528Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer

Novartis Pharmaceuticals·interventional·Posted Nov 26, 2003·Updated Feb 24, 2021

In Brief

A Phase 3 clinical trial evaluating Lapatinib, Letrozole, and 1 other intervention for Breast Neoplasms. Completed, enrolled 1,286 participants across 278 sites in 29 countries.

Detailed Summary

This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, France, Germany, Hungary, Ireland, Italy, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Russia, South Africa, South Korea, Spain, Tunisia, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 26, 2003
Enrollment StartDec 9, 2003
Primary CompletionJun 3, 2008
Study CompletionMar 22, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 22.6 years ago

Interventions

Lapatinibdrug

1500 mg orally once a day

Letrozoledrug

2.5 mg orally once a day

Placebodrug

Placebo (which matched with lapatinib tablet)