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Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Sponsor: National Cancer Institute (NCI)
Summary
This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.
Official title: Randomized Phase III Trial of Paclitaxel +Trastuzumab + Lapatinib Versus Paclitaxel + Trastuzumab as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
305
Start Date
2009-02-24
Completion Date
2024-02-15
Last Updated
2026-08-12
Healthy Volunteers
No
Conditions
Interventions
Laboratory Biomarker Analysis
Correlative studies
Lapatinib Ditosylate
Given PO
Paclitaxel
Given IV
Trastuzumab
Given IV
Locations (318)
Banner University Medical Center - Tucson
Tucson, Arizona, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, 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
Contra Costa Regional Medical Center
Martinez, California, United States
El Camino Hospital
Mountain View, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Wilma Chan Highland Hospital
Oakland, 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
Tom K Lee Inc
Oakland, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, 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
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Saint Helena Hospital
St. Helena, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Foothills Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
AdventHealth Porter
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western States Cancer Research NCORP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Banner North Colorado Medical Center
Greeley, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
AdventHealth Littleton
Littleton, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
Banner McKee Medical Center
Loveland, Colorado, United States
AdventHealth Parker
Parker, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Manchester Memorial Hospital
Manchester, Connecticut, United States
Middlesex Hospital
Middletown, 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
Halifax Health Medical Center-Centers for Oncology
Daytona Beach, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Cancer Specialists-Gainesville Cancer Center
Gainesville, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Cleveland Clinic-Weston
Weston, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Atlanta Regional CCOP
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
WellStar Cobb Hospital
Austell, Georgia, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Emory Decatur Hospital
Decatur, Georgia, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia, United States
Atrium Health Navicent
Macon, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Southern Regional Medical Center
Riverdale, Georgia, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
OSF Saint Anthony's Health Center
Alton, Illinois, United States
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Presence Resurrection Medical Center
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Duly Health and Care Joliet
Joliet, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Swedish American Hospital
Rockford, Illinois, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Reid Health
Richmond, Indiana, United States
McFarland Clinic - Ames
Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States
Mercy Capitol
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States