Clinical trialNCT00390455CompletedPhase 3Interventional

Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

SponsorNational Cancer Institute (NCI)Enrollment295Estrogen Receptor PositiveHER2 Positive Breast CarcinomaHER2/Neu NegativeProgesterone Receptor PositiveRecurrent Breast CarcinomaStage IIIB Breast Cancer AJCC v7+2 more conditions

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Harold J Burstein
Alliance for Clinical Trials in Oncology
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

368 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Arroyo Grande Community
Arroyo Grande, California, United States
Pcr Oncology
Arroyo Grande, California, United States
Providence Saint Joseph Medical Center/disney Family Cancer Center
Burbank, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Glendale Memorial Hospital and Health Center
Glendale, California, United States
Saint Rose Hospital
Hayward, California, United States
Fremont - Rideout Cancer Center
Marysville, California, United States
El Camino Hospital
Mountain View, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Highland General Hospital
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Salinas Valley Memorial
Salinas, California, United States
Kaiser Permanente-San Diego Mission
San Diego, California, United States
Ucsf Medical Center-Mount Zion
San Francisco, California, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
Doctors Medical Center- Jc Robinson Regional Cancer Center
San Pablo, California, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, United States
Northbay Cancer Center
Vacaville, California, United States
Uchealth Memorial Hospital Central
Colorado Springs, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Saint Vincent'S Medical Center
Bridgeport, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, United States
Harold Leever Regional Cancer Center
Waterbury, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States

328 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Fulvestrant →Lapatinib →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 15 Sept 2006
Primary completion: 1 Jul 2014
Completion: 2 Jul 2014
Last update posted: 20 Dec 2019
Registered enrollment: 295
Registry id: NCT00390455

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.