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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
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
HaysMed
Hays, Kansas, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Mercy Hospital Pittsburg
Pittsburg, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Christiana Care - Union Hospital
Elkton, Maryland, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Beacon Kalamazoo
Kalamazoo, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
MyMichigan Medical Center Saginaw
Saginaw, Michigan, United States
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, United States
Henry Ford Health Warren Hospital
Warren, Michigan, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Center for Cancer Care and Research
St Louis, Missouri, United States
Comprehensive Cancer Care PC
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Center
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, United States
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States
Dartmouth Cancer Center - Manchester
Manchester, New Hampshire, United States
Elliot Hospital
Manchester, New Hampshire, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, United States
Foundation Medical Partners
Nashua, New Hampshire, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers New Jersey Medical School
Newark, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, United States
Hematology Oncology Associates
Albuquerque, New Mexico, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Elmhurst Hospital Center
Elmhurst, New York, United States
Queens Hospital Center
Jamaica, New York, United States
Northwell Health NCORP
Lake Success, New York, United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Garnet Health Medical Center
Middletown, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
ECU Health Oncology Kinston
Kinston, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
UNC Rex Healthcare
Raleigh, North Carolina, United States
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
Washington, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Saint Alexius Medical Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, United States
Aultman Health Foundation
Canton, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
University Hospitals Parma Medical Center
Parma, Ohio, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington, Ohio, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Kent Hospital
Warwick, Rhode Island, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Roper Hospital
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Self Regional Healthcare
Greenwood, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Nashville Oncology Associates PC
Nashville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
Doctor's Hospital of Laredo
Laredo, Texas, United States
Texas Tech University Health Sciences Center-Lubbock
Lubbock, Texas, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, United States
University of Vermont and State Agricultural College
Burlington, Vermont, United States
Danville Regional Medical Center
Danville, Virginia, United States
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, United States
MultiCare Auburn Medical Center
Auburn, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
EvergreenHealth Medical Center
Kirkland, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Pacific Medical Center-First Hill
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Saint Michael Cancer Center
Silverdale, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States
Providence Holy Family Hospital
Spokane, Washington, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, United States
MultiCare Allenmore Hospital
Tacoma, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Saint Mary's Medical Center
Huntington, West Virginia, United States
Camden Clark Medical Center
Parkersburg, West Virginia, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, United States
Welch Cancer Center
Sheridan, Wyoming, United States
San Juan City Hospital
San Juan, Puerto Rico