MedTrace Logo

Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

NCT00073528 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1286

Last updated 2021-02-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Lapatinib

1500 mg orally once a day

DRUG

Letrozole

2.5 mg orally once a day

DRUG

Placebo

Placebo (which matched with lapatinib tablet)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-09
Primary Completion
2008-06-03
Completion
2018-03-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT00073528 on ClinicalTrials.gov