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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00073528

Public ClinicalTrials.gov record NCT00073528. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00073528
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
1,286 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 9, 2003 (Actual)
Primary completion
Jun 3, 2008 (Actual)
Completion
Mar 22, 2018 (Actual)
Last update posted
Feb 24, 2021

2003 – 2018

United States locations

U.S. sites
84
U.S. states
32
U.S. cities
81
Facility City State ZIP Site status
Novartis Investigative Site Tucson Arizona 85715 —
Novartis Investigative Site Hot Springs Arkansas 71913 —
Novartis Investigative Site Jonesboro Arkansas 72401 —
Novartis Investigative Site Alhambra California 91801 —
Novartis Investigative Site Bakersfield California 93309 —
Novartis Investigative Site Duarte California 91010 —
Novartis Investigative Site Fountain Valley California 92708 —
Novartis Investigative Site Fresno California 93710 —
Novartis Investigative Site Fullerton California 92835 —
Novartis Investigative Site La Jolla California 92093-0987 —
Novartis Investigative Site Long Beach California 90813 —
Novartis Investigative Site Los Angeles California 90095 —
Novartis Investigative Site Montebello California 90640 —
Novartis Investigative Site Northridge California 91325 —
Novartis Investigative Site Oxnard California 93030 —
Novartis Investigative Site Pleasant Hill California 94523 —
Novartis Investigative Site Porterville California 93257 —
Novartis Investigative Site Redondo Beach California 90277 —
Novartis Investigative Site San Diego California 92120 —
Novartis Investigative Site Santa Barbara California 93105 —
Novartis Investigative Site Santa Maria California 93454 —
Novartis Investigative Site Vallejo California 94589 —
Novartis Investigative Site Vista California 92081 —
Novartis Investigative Site Aurora Colorado 80045 —
Novartis Investigative Site Denver Colorado 80220 —
Novartis Investigative Site Longmont Colorado 80501 —
Novartis Investigative Site Wheat Ridge Colorado 80033 —
Novartis Investigative Site New Haven Connecticut 06520 —
Novartis Investigative Site Boca Raton Florida 33428 —
Novartis Investigative Site Boca Raton Florida 33486 —
Novartis Investigative Site Gainesville Florida 32605 —
Novartis Investigative Site Gainesville Florida 32610 —
Novartis Investigative Site Hollywood Florida 33021 —
Novartis Investigative Site Lakeland Florida 33805 —
Novartis Investigative Site Miami Florida 33136 —
Novartis Investigative Site Orlando Florida 32804 —
Novartis Investigative Site Port Saint Lucie Florida 34952 —
Novartis Investigative Site West Palm Beach Florida 33401 —
Novartis Investigative Site Atlanta Georgia 30341 —
Novartis Investigative Site Marietta Georgia 30060 —
Novartis Investigative Site Savannah Georgia 31406 —
Novartis Investigative Site Peoria Illinois 61615 —
Novartis Investigative Site Skokie Illinois 60076 —
Novartis Investigative Site Indianapolis Indiana 46202 —
Novartis Investigative Site Bettendorf Iowa 52722 —
Novartis Investigative Site Louisville Kentucky 40202 —
Novartis Investigative Site Metairie Louisiana 70006 —
Novartis Investigative Site New Orleans Louisiana 70121 —
Novartis Investigative Site Worcester Massachusetts 01608 —
Novartis Investigative Site Duluth Minnesota 55805 —
Novartis Investigative Site Minneapolis Minnesota 55407-3799 —
Novartis Investigative Site Robbinsdale Minnesota 55422 —
Novartis Investigative Site Saint Louis Park Minnesota 55426 —
Novartis Investigative Site Saint Charles Missouri 63304 —
Novartis Investigative Site St Louis Missouri 63141 —
Novartis Investigative Site Omaha Nebraska 68114 —
Novartis Investigative Site Las Vegas Nevada 89169 —
Novartis Investigative Site Voorhees Township New Jersey 08043 —
Novartis Investigative Site Santa Fe New Mexico 87505 —
Novartis Investigative Site Manhasset New York 11030 —
Novartis Investigative Site Rochester New York 14623 —
Novartis Investigative Site Chapel Hill North Carolina 27599-7305 —
Novartis Investigative Site Greenville North Carolina 27834 —
Novartis Investigative Site Fargo North Dakota 58103 —
Novartis Investigative Site Canton Ohio 44718 —
Novartis Investigative Site Hershey Pennsylvania 17033 —
Novartis Investigative Site Philadelphia Pennsylvania 19111 —
Novartis Investigative Site Pittsburgh Pennsylvania 15212 —
Novartis Investigative Site West Columbia South Carolina 29210 —
Novartis Investigative Site Germantown Tennessee 38138 —
Novartis Investigative Site Knoxville Tennessee 37916 —
Novartis Investigative Site Amarillo Texas 79106 —
Novartis Investigative Site Dallas Texas 75246 —
Novartis Investigative Site Dallas Texas 75390-9113 —
Novartis Investigative Site Houston Texas 77025 —
Novartis Investigative Site Irving Texas 75061 —
Novartis Investigative Site Ogden Utah 84403 —
Novartis Investigative Site Salt Lake City Utah 84106 —
Novartis Investigative Site Burlington Vermont 05401 —
Novartis Investigative Site Danville Virginia 24541 —
Novartis Investigative Site Richmond Virginia 23230 —
Novartis Investigative Site Seattle Washington 98104 —
Novartis Investigative Site Tacoma Washington 98405 —
Novartis Investigative Site Charleston West Virginia 25304 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 194 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00073528, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 24, 2021 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00073528 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →