Can a triple drug combo shrink HER2-Positive breast tumors before surgery?

NCT ID NCT00770809

Completed Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This phase III trial is investigating whether adding lapatinib to the standard combination of paclitaxel and trastuzumab before surgery can improve outcomes for patients with HER2-positive stage II or III breast cancer. The study aims to see if the three-drug regimen leads to a higher rate of complete tumor disappearance (pathologic complete response) at the time of surgery compared to the two-drug regimen. Participants receive either paclitaxel plus trastuzumab with or without lapatinib before their surgical removal of the tumor. The goal is to determine which approach is more effective in reducing tumor size and potentially allowing for less extensive surgery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: lapatinib ditosylate (Tykerb) added to paclitaxel and trastuzumab
What this could lead to: If adding lapatinib works, it could shrink HER2-positive breast tumors more effectively before surgery, potentially reducing the extent of surgery needed and improving long-term outcomes.
What could go wrong: This is a phase III trial, but results are not yet known. Adding lapatinib may increase side effects without improving response, and the benefit may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma male breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MALE BREAST CARCINOMA STAGE IIA BREAST CANCER AJCC V6 AND V7 STAGE IIB BREAST CANCER AJCC V6 AND V7 STAGE IIIA BREAST CANCER AJCC V7 STAGE IIIB BREAST CANCER AJCC V7 STAGE IIIC BREAST CANCER AJCC V7

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Advocate Christ Medical Center

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Atrium Health Navicent

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Banner University Medical Center - Tucson

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Bay Area Breast Surgeons Inc

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Bay Area Tumor Institute

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Beacon Kalamazoo

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Beebe Medical Center

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Benefis Sletten Cancer Institute

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Berdeaux, Donald MD (UIA Investigator)

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Billings Clinic Cancer Center

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Central Vermont Medical Center/National Life Cancer Treatment

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Cleveland Clinic Wooster Family Health and Surgery Center

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Cleveland Clinic-Weston

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Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center

Wilmington, Ohio, 45177, United States
Community Medical Center

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Comprehensive Cancer Care PC

St Louis, Missouri, 63141, United States
Cone Health Cancer Center at Alamance Regional

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Contra Costa Regional Medical Center

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Cooper Hospital University Medical Center

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Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States
Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, 66606, United States
Creighton University Medical Center

Omaha, Nebraska, 68131, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute at Boston Medical Center - Brighton

Brighton, Massachusetts, 02135, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

Milford, Massachusetts, 01757, United States
Danville Regional Medical Center

Danville, Virginia, 24541, United States
Dartmouth Cancer Center - Manchester

Manchester, New Hampshire, 03102, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756, United States
Dayton NCI Community Oncology Research Program

Dayton, Ohio, 45459, United States
Desert Regional Medical Center

Palm Springs, California, 92262, United States
Doctor's Hospital of Laredo

Laredo, Texas, 78041, United States
Doctors Medical Center- JC Robinson Regional Cancer Center

San Pablo, California, 94806, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Duly Health and Care Joliet

Joliet, Illinois, 60435, United States
ECU Health Oncology Kinston

Kinston, North Carolina, 28501, United States
East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States
East Carolina University

Greenville, North Carolina, 27834, United States
Eastern Maine Medical Center

Bangor, Maine, 04401, United States
Eden Hospital Medical Center

Castro Valley, California, 94546, United States
El Camino Hospital

Mountain View, California, 94040, United States
Elliot Hospital

Manchester, New Hampshire, 03103, United States
Elmhurst Hospital Center

Elmhurst, New York, 11373, United States
Emory Decatur Hospital

Decatur, Georgia, 30033, United States
Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States
Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States
Evergreen Hematology and Oncology PS

Spokane, Washington, 99218, United States
EvergreenHealth Medical Center

Kirkland, Washington, 98033, United States
FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, 28374, United States
Florida Cancer Specialists-Gainesville Cancer Center

Gainesville, Florida, 32605, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview

Fort Wayne, Indiana, 46845, United States
Foundation Medical Partners

Nashua, New Hampshire, 03060, United States
Franciscan Saint Francis Health-Beech Grove

Beech Grove, Indiana, 46107, United States
Garnet Health Medical Center

Middletown, New York, 10940, United States
Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States
Genesys Regional Medical Center-West Flint Campus

Flint, Michigan, 48532, United States
Glacier Oncology PLLC

Kalispell, Montana, 59901, United States
Good Samaritan Hospital - Dayton

Dayton, Ohio, 45406, United States
Grandview Hospital

Dayton, Ohio, 45405, United States
Great Falls Clinic

Great Falls, Montana, 59405, United States
Greene Memorial Hospital

Xenia, Ohio, 45385, United States
Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, 29601, United States
Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States
Halifax Health Medical Center-Centers for Oncology

Daytona Beach, Florida, 32114, United States
Harbin Clinic Medical Oncology and Clinical Research

Rome, Georgia, 30165, United States
Harold Alfond Center for Cancer Care

Augusta, Maine, 04330, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo

Poulsbo, Washington, 98370, United States
HaysMed

Hays, Kansas, 67601, United States
Hematology Oncology Associates

Albuquerque, New Mexico, 87106, United States
Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, 13057, United States
Hematology Oncology Associates of Fredericksburg Inc

Fredericksburg, Virginia, 22408, United States
Hematology and Oncology Associates-Oakland

Oakland, California, 94609, United States
Henry Ford Health Providence Southfield Hospital

Southfield, Michigan, 48075, United States
Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236, United States
Henry Ford Health Warren Hospital

Warren, Michigan, 48093, United States
Highline Medical Center-Main Campus

Burien, Washington, 98166, United States
Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124, United States
Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States
Holy Cross Hospital

Silver Spring, Maryland, 20910, United States
Hurley Medical Center

Flint, Michigan, 48503, United States
Hutchinson Regional Medical Center

Hutchinson, Kansas, 67502, United States
Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, 80401, United States
Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP

Des Moines, Iowa, 50309, United States
John B Amos Cancer Center

Columbus, Georgia, 31904, United States
Jupiter Medical Center

Jupiter, Florida, 33458, United States
Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States
Kaiser Permanente Washington

Seattle, Washington, 98112, United States
Kalispell Medical Oncology

Kalispell, Montana, 59901, United States
Kent Hospital

Warwick, Rhode Island, 02886, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
LRGHealthcare-Lakes Region General Hospital

Laconia, New Hampshire, 03246, United States
Lake Huron Medical Center

Port Huron, Michigan, 48060, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States
Lewistown Hospital

Lewistown, Pennsylvania, 17044, United States
Lexington Medical Center

West Columbia, South Carolina, 29169, United States
Logan Health Medical Center

Kalispell, Montana, 59901, United States
Long Island Jewish Medical Center

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Longmont United Hospital

Longmont, Colorado, 80501, United States
Lovelace Medical Center-Saint Joseph Square

Albuquerque, New Mexico, 87102, United States
Loyola University Medical Center

Maywood, Illinois, 60153, United States
MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109, United States
Manchester Memorial Hospital

Manchester, Connecticut, 06040, United States
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital

Washington, North Carolina, 27889, United States
Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States
Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, 56001, United States
McFarland Clinic - Ames

Ames, Iowa, 50010, United States
MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States
Meharry Medical College

Nashville, Tennessee, 37208, United States
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703, United States
Mercy Capitol

Des Moines, Iowa, 50307, United States
Mercy Hospital Pittsburg

Pittsburg, Kansas, 66762, United States
Mercy Hospital Saint Louis

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Mercy Infusion Center - Chippewa

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Mercy Medical Center-Sioux City

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Miami Valley Hospital

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Miami Valley Hospital North

Dayton, Ohio, 45415, United States
Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States
Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States
Middlesex Hospital

Middletown, Connecticut, 06457, United States
Minor and James Medical PLLC

Seattle, Washington, 98104, United States
Mission Hospital

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Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Missouri Valley Cancer Consortium

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Billings, Montana, 59102, United States
Montana Cancer Specialists

Missoula, Montana, 59802, United States
Morristown Medical Center

Morristown, New Jersey, 07960, United States
Mount Nittany Medical Center

State College, Pennsylvania, 16803, United States
Mount Sinai Hospital Medical Center

Chicago, Illinois, 60608, United States
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Miami Beach, Florida, 33140, United States
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Auburn, Washington, 98001, United States
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Puyallup, Washington, 98372, United States
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Tacoma, Washington, 98405, United States
MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States
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Nashville, Tennessee, 37203, United States
Nebraska Cancer Research Center

Lincoln, Nebraska, 68510, United States
Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, 89120, United States
New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301, United States
Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States
North Shore University Hospital

Manhasset, New York, 11030, United States
North Suburban Medical Center

Thornton, Colorado, 80229, United States
Northern Montana Hospital

Havre, Montana, 59501, United States
Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States
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Atlanta, Georgia, 30342, United States
Northside Hospital - Gwinnett

Lawrenceville, Georgia, 30046, United States
Northwell Health NCORP

Lake Success, New York, 11042, United States
Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States
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Tacoma, Washington, 98405, United States
OSF Saint Anthony's Health Center

Alton, Illinois, 62002, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
Overlook Hospital

Summit, New Jersey, 07902, United States
Pacific Medical Center-First Hill

Seattle, Washington, 98104, United States
Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States
Palo Alto Medical Foundation-Camino Division

Mountain View, California, 94040, United States
PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States
PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States
Piedmont Fayette Hospital

Fayetteville, Georgia, 30214, United States
Piedmont Hospital

Atlanta, Georgia, 30309, United States
Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218, United States
Presence Resurrection Medical Center

Chicago, Illinois, 60631, United States
Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Easley

Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Faris

Greenville, South Carolina, 29605, United States
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Greer, South Carolina, 29650, United States
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Seneca, South Carolina, 29672, United States
Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, 29316, United States
Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States
Providence - Saint Peter Hospital

Olympia, Washington, 98506-5166, United States
Providence Holy Family Hospital

Spokane, Washington, 99208, United States
Providence Regional Cancer System-Centralia

Centralia, Washington, 98531, United States
Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, 99204, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States
Queens Hospital Center

Jamaica, New York, 11432, United States
Reid Health

Richmond, Indiana, 47374, United States
Renown Regional Medical Center

Reno, Nevada, 89502, United States
Roper Hospital

Charleston, South Carolina, 29401, United States
Rose Medical Center

Denver, Colorado, 80220, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Rutgers New Jersey Medical School

Newark, New Jersey, 07101, United States
SSM Health Good Samaritan

Mount Vernon, Illinois, 62864, United States
Saint Alexius Medical Center

Bismarck, North Dakota, 58501, United States
Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706, United States
Saint Anthony Hospital

Lakewood, Colorado, 80228, United States
Saint Clare Hospital

Lakewood, Washington, 98499, United States
Saint Francis Hospital

Greenville, South Carolina, 29601, United States
Saint Francis Hospital

Federal Way, Washington, 98003, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint Helena Hospital

St. Helena, California, 94574, United States
Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, 59701, United States
Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, 80218, United States
Saint Joseph Medical Center

Tacoma, Washington, 98405, United States
Saint Louis-Cape Girardeau CCOP

St Louis, Missouri, 63141, United States
Saint Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States
Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States
Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501, United States
Saint Mary's Medical Center

Huntington, West Virginia, 25702, United States
Saint Michael Cancer Center

Silverdale, Washington, 98383, United States
Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802, United States
Saint Peter's Community Hospital

Helena, Montana, 59601, United States
Saint Rita's Medical Center

Lima, Ohio, 45801, United States
Saint Vincent Frontier Cancer Center

Billings, Montana, 59102, United States
Saint Vincent Healthcare

Billings, Montana, 59101, United States
Salina Regional Health Center

Salina, Kansas, 67401, United States
Salinas Valley Memorial

Salinas, California, 93901, United States
San Juan City Hospital

San Juan, 00936, Puerto Rico
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Self Regional Healthcare

Greenwood, South Carolina, 29646, United States
Siouxland Regional Cancer Center

Sioux City, Iowa, 51101, United States
Skagit Valley Hospital

Mount Vernon, Washington, 98274, United States
Sky Ridge Medical Center

Lone Tree, Colorado, 80124, United States
Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States
Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103, United States
Southeast Missouri Hospital

Cape Girardeau, Missouri, 63701, United States
Southern Regional Medical Center

Riverdale, Georgia, 30274, United States
Sparks Regional Medical Center

Fort Smith, Arkansas, 72901, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Sturdy Memorial Hospital

Attleboro, Massachusetts, 02703, United States
Swedish American Hospital

Rockford, Illinois, 61104, United States
Swedish Medical Center

Englewood, Colorado, 80113, United States
Swedish Medical Center-First Hill

Seattle, Washington, 98122, United States
Texas Tech University Health Sciences Center-Lubbock

Lubbock, Texas, 79430, United States
The Medical Center of Aurora

Aurora, Colorado, 80012, United States
TidalHealth Peninsula Regional

Salisbury, Maryland, 21801, United States
Tom K Lee Inc

Oakland, California, 94609, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UCSF Medical Center-Mount Zion

San Francisco, California, 94115, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UNC Rex Healthcare

Raleigh, North Carolina, 27607, United States
UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505, United States
University Health Truman Medical Center

Kansas City, Missouri, 64108, United States
University Hospitals Parma Medical Center

Parma, Ohio, 44129, United States
University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, 52722, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States
University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States
University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Vermont and State Agricultural College

Burlington, Vermont, 05405, United States
University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States
Upper Valley Medical Center

Troy, Ohio, 45373, United States
Valley Care Health System - Pleasanton

Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants

Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants-Castro Valley

Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Fremont

Fremont, California, 94538, United States
Vassar Brothers Medical Center

Poughkeepsie, New York, 12601, United States
Virginia Mason Medical Center

Seattle, Washington, 98101, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wayne Hospital

Greenville, Ohio, 45331, United States
Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States
Weiss Memorial Hospital

Chicago, Illinois, 60640, United States
Welch Cancer Center

Sheridan, Wyoming, 82801, United States
WellStar Cobb Hospital

Austell, Georgia, 30106, United States
Wellstar Kennestone Hospital

Marietta, Georgia, 30060, United States
Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
Western States Cancer Research NCORP

Denver, Colorado, 80222, United States
Wilma Chan Highland Hospital

Oakland, California, 94602, United States
Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

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