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Completed Phase 3 Interventional Results available

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer

ClinicalTrials.gov ID: NCT00878709

Public ClinicalTrials.gov record NCT00878709. 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 19, 2026, 9:35 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 Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

Brief summary

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

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Study identification

NCT ID
NCT00878709
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Puma Biotechnology, Inc.
Industry
Enrollment
2,840 participants

Conditions and interventions

Conditions

Interventions

Drug · Other

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
Jul 9, 2009 (Actual)
Primary completion
Aug 21, 2014 (Actual)
Completion
Oct 4, 2019 (Actual)
Last update posted
Jun 11, 2021

2009 – 2019

United States locations

U.S. sites
185
U.S. states
42
U.S. cities
150
Facility City State ZIP Site status
Anniston Oncology Anniston Alabama 36207 —
Birmingham Hematology and Oncology Associates, LLC Birmingham Alabama 35205 —
Arizona Oncology Associates, PC - HAL Phoenix Arizona 85016 —
Arizona Oncology Associates, PC - NAHOA Sedona Arizona 86336 —
Arizona Oncology Associates Tucson Arizona 85704-7891 —
Arizona Cancer Center Tucson Arizona 85724 —
Northeast Arkansas Clinic Jonesboro Arkansas 72401 —
Cedars-Sinai Medical Group Beverly Hills California 90211 —
Ronald Yanagihara, M.D. Gilroy California 95020 —
Glendale Adventist Medical Center Cancer Services Glendale California 91206 —
California Cancer Care Greenbrae California 94904 —
Beaver Medical Group, L.P. Highland California 92346 —
Breastlink Medical Group Long Beach California 90806 —
Long Beach Memorial Medical Center Long Beach California 90806 —
Facey Medical Group Mission Hills California 91345 —
Gynecologic Oncology Associates Newport Beach California 92663 —
Ventura County Hematology-Oncology Specialists Oxnard California 93030 —
Desert Hematology Oncology Medical Group, Inc Rancho Mirage California 92270 —
Helen Diller Family University of California San Francisco Comprehensive Cancer Center San Francisco California 94115 —
San Francisco Oncology Associates San Francisco California 94115 —
Redwood Regional Medical Group Santa Rosa California 95403 —
The Cancer Prevention and Treatment Center Soquel California 95073 —
Cancer Center of Central Connecticut Southington Connecticut 06489 —
Hematology Oncology, PC Stamford Connecticut 06902 —
Connecticut Oncology and Hematology Torrington Connecticut 06790 —
Washington Cancer Institute at Washington Hospital Center Washington D.C. District of Columbia 20010 —
Innovative Medical Research of South Florida, Inc. Aventura Florida 33180 —
University Cancer Institute, LLC Boynton Beach Florida 33426 —
North Broward Medical Center Deerfield Beach Florida 33064 —
Broward General Medical Center Fort Lauderdale Florida 33316 —
Florida Cancer Specialists and Research Institute Gainesville Florida 32605 —
Lakeland Regional Cancer Center Lakeland Florida 33805 —
Hematology Oncology Associates Loxahatchee Groves Florida 33470 —
Florida Cancer Affiliates - Ocala Ocala Florida 34471 —
Mid-Florida Hematology & Oncology Centers, PA Orange City Florida 32763-8316 —
Cancer Centers of Florida Orlando Florida 32806 —
M.D. Anderson Cancer Center Orlando Orlando Florida 32806 —
Florida Cancer Research Institute Plantation Florida 33324 —
Hematology Oncology Associates of Treasure Coast Port Saint Lucie Florida 34592 —
Florida Cancer Specialists, P.L. St. Petersburg Florida 33705 —
Oncology and Hematology of West Broward Tamarac Florida 33321 —
Florida Medical Clinic, P.A. Zephyrhills Florida 33542 —
Phoebe Cancer Center Albany Georgia 31701 —
Piedmont Cancer Institute Atlanta Georgia 30318 —
Augusta Oncology Associates (ACORN), P.C. Augusta Georgia 30909 —
Dwight David Eisenhower Army Medical Center Fort Gordon Georgia 30905-5650 —
Straub Clinic & Hospital Honolulu Hawaii 96813-3083 —
Portneuf Medical Center Pocatello Idaho 83201 —
Rush University Medical Center Chicago Illinois 60612 —
Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research Decatur Illinois 62526 —
Midwest Center for Hematology/Oncology Joliet Illinois 60432 —
Medical Arts Associates, Ltd Moline Illinois 61265 —
Advocate Medical Group Niles Illinois 60714 —
Cancer Care & Hematology Specialists of Chicagoland Niles Illinois 60714 —
Quincy Medical Group, Cancer Center at Blessing Hospital Quincy Illinois 62301 —
North Shore Cancer Research Associates Skokie Illinois 60076 —
Orchard Healthcare Research, Inc. Skokie Illinois 60076 —
Orchard Research, LLC Skokie Illinois 60076 —
Simmons Cancer Institute Springfield Illinois 62702 —
Springfield Clinic, LLP Springfield Illinois 62702 —
Midwestern Regional Medical Center Zion Illinois 60099 —
Central Indiana Cancer Centers Indianapolis Indiana 46219 —
Hematology Oncology of Indiana Indianapolis Indiana 46260-2082 —
Community Hospital Munster Indiana 46321 —
Ashland-Bellefonte Cancer Center Ashland Kentucky 41101-7016 —
Purchase Cancer Group Paducah Kentucky 42001 —
Hematology-Oncology Clinic Baton Rouge Louisiana 70809 —
Crescent City Research Consortium, LLC Marrero Louisiana 70072 —
Central Maine Healthcare Corp Lewiston Maine 04240 —
Mercy Hospital Oncology/Hematology Center Portland Maine 04102 —
York Hospital Oncology Treatment Center York Village Maine 03909 —
Medical Oncology & Hematology Mercy Medical Center Baltimore Maryland 21202 —
Harry and Jeanette Weinberg Cancer Center Baltimore Maryland 21237 —
Alliance Hematology Oncology, PA Carroll County Cancer Center Westminster Maryland 21157 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Massachusetts General Hospital - Gillette Center Boston Massachusetts 02215 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01655 —
Barbara Ann Karmanos Cancer Institute Detroit Michigan 48201-2013 —
Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan 49503 —
Medical Specialty Associates Grand Rapids Michigan 49503 —
Northern Michigan Hematology/Oncology Petoskey Michigan 49770 —
Minnesota Oncology Hematology, PA Minneapolis Minnesota 55404 —
Park Nicollet Institute Saint Louis Park Minnesota 55426 —
North Mississippi Hematology and Oncology Associates, Ltd. Tupelo Mississippi 38801 —
Capitol Comprehensive Cancer Care Clinic Jefferson City Missouri 65109 —
St. Joseph's Oncology Saint Joseph Missouri 64507 —
Mercy Medical Research Institute Springfield Missouri 65807 —
Washington University School of Medicine Siteman Cancer Center St Louis Missouri 63110 —
Montana Cancer Specialists Missoula Montana 59802 —
Southeast Nebraska Hematology & Oncology Consultants, PC Lincoln Nebraska 68510 —
Great Plains Regional Medical Center North Platte Nebraska 69101 —
The Center for Cancer and Hematologic Disease Cherry Hill New Jersey 08003 —
Trinitas Comprehensive Cancer Center Elizabeth New Jersey 07207 —
Saint Barnabas Health Care System Livingston New Jersey 07039 —
Summit Medical Group Morristown New Jersey 07960 —
Oncology and Hematology Specialist Mountain Lakes New Jersey 07046 —
Jersey Shore University Medical Center Neptune City New Jersey 07754 —
The Valley Hospital, Luckow Pavilion Paramus New Jersey 07652 —
Cooper University Hospital Voorhees Township New Jersey 08043-4689 —
ProHealth Care Associates Lake Success New York 11042 —
NYU Clinical Cancer Center New York New York 10016 —
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center New York New York 10032 —
Eastchester Center for Cancer Care The Bronx New York 10469 —
NorthEast Oncology Associates Carolinas Medical Center NorthEast Concord North Carolina 28025 —
Duke University Medical Center Medical Oncology Durham North Carolina 27710 —
Raleigh Hematology Oncology Associates Cancer Centers of North Carolina Raleigh North Carolina 27607 —
Hanover Medical Specialists, PA Wilmington North Carolina 28401 —
Mid Dakota Clinic, PC Bismarck North Dakota 58501 —
The Christ Hospital Cancer Center Cincinnati Ohio 45219 —
University of Cincinnati Cincinnati Ohio 45267 —
University Hospitals, Cleveland Medical Center Cleveland Ohio 44106 —
MetroHealth Medical Center Cleveland Ohio 44109 —
Signal Point Hematology/Oncology, Inc. Middletown Ohio 45042 —
Mercy Physicians of Oklahoma Oklahoma City Oklahoma 73120 —
Bend Memorial Clinic Bend Oregon 97701 —
Samaritan Hematology & Oncology Consultants Corvallis Oregon 97330 —
Northwest Cancer Specialist, P.C. Portland Oregon 97213 —
Providence Cancer Center Oncology and Hematology Care - Westside Portland Oregon 97213 —
Kaiser Permanente Northwest Region Oncology Hematology Portland Oregon 97227-1110 —
Oregon Health and Science University Portland Oregon 97239 —
Willamette Valley Cancer Institute and Research Center Springfield Oregon 97477 —
Oncology-Hematology of Lehigh Valley, PC Bethlehem Pennsylvania 18015 —
Gettysburg Cancer Center Gettysburg Pennsylvania 17325 —
Pinnacle Health Cancer Center Community Campus Harrisburg Pennsylvania 17109 —
Sweeney-Melenyser Pavillion Monongahela Pennsylvania 15063 —
Perelman Center for Advanced Medicine Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Temple University Hospital Philadelphia Pennsylvania 19140 —
Albert Einstein Cancer Center Philadelphia Pennsylvania 19141 —
Guthrie Clinic, Limited Sayre Pennsylvania 18840 —
Abington Hematology Oncology Associates, Inc Willow Grove Pennsylvania 19090-1137 —
Pawtuket Memorial Hospital Pawtucket Rhode Island 02860 —
Charleston Hematology Oncology Associates, PA Charleston South Carolina 29414 —
Medical University of South Carolina Hollings Cancer Center Charleston South Carolina 29425 —
Francisco Gonzalez MD PA Columbia South Carolina 29203 —
McLeod Oncology and Hematology Associates Florence South Carolina 29506 —
South Carolina Cancer Specialists Hilton Head Island South Carolina 29926 —
Santee Hematology Oncology Sumter South Carolina 29150 —
Avera Medical Oncology and Hematology - Avera Cancer Institute Sioux Falls South Dakota 57105 —
University Hematology/Oncology Associates PLLC Chattanooga Tennessee 37403 —
Cookeville Regional Cancer Center Cookeville Tennessee 38501 —
The Jones Clinic, PC Germantown Tennessee 38138 —
Thompson Cancer Survival Center Knoxville Tennessee 37916 —
Nashville Breast Center Nashville Tennessee 37203 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232 —
Texas Oncology, P.A. Austin Texas 78731 —
Texas Oncology, P.A. Bedford Texas 76022 —
Coastal Bend Cancer Center Corpus Christi Texas 78404 —
South Texas Institute of Cancer Corpus Christi Texas 78405 —
Cancer Specialists of South Texas, P.A. Corpus Christi Texas 78412 —
Center for Oncology Research Dallas Texas 75230 —
Texas Oncology, P.A. Dallas Texas 75231-4400 —
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246 —
University of Texas Southwestern Medical Center Simmons Cancer Center Dallas Texas 75390 —
Texas Oncology, P.A. Denton Texas 76210 —
El Paso Cancer Treatment Center - West El Paso Texas 79902 —
Center for Integrative Cancer Medicine, PA El Paso Texas 79912 —
Texas Oncology Fort Worth Texas 76104 —
Texas Oncology, P.A. Garland Texas 75042 —
Texas Oncology - Memorial City Houston Texas 77024 —
The Methodist Hospital Breast Center Houston Texas 77030 —
Medicus Alliance Clinical Research Org., Inc. Houston Texas 77055 —
Jabboury Foundation for Cancer Research, Inc. Houston Texas 77082 —
Texas Oncology, P.A. Paris Texas 75460 —
Cancer Care Centers of South Texas San Antonio Texas 78217 —
South Texas Oncology & Hematology San Antonio Texas 78229 —
Texas Oncology P.A. Sugar Land Texas 77479 —
East Texas Medical Center Cancer Institute Tyler Texas 75701 —
Texas Oncology Tyler Texas 75702 —
Texas Oncology Cancer Care and Research Center Waco Texas 76712 —
North Utah Associates Ogden Utah 84403 —
Utah Cancer Specialists Salt Lake City Utah 84106 —
Southwestern Vermont Regional Cancer Center Bennington Vermont 05201 —
Rutland Regional Medical Center Rutland Vermont 05701 —
Inova Schar Cancer Institute Fairfax Virginia 22031 —
Virginia Cancer Specialists, PC Fairfax Virginia 22031 —
Virginia Oncology Associates Norfolk Virginia 23502 —
Cascade Cancer Center Kirkland Washington 98034 —
Cancer Care Northwest-North Spokane Washington 99202 —
Northwest Medical Specialties PLLC Tacoma Washington 98405 —
Wenatchee Valley Medical Center Wenatchee Washington 98801 —
West Virginia University Mary Babb Randolph Cancer Center Morgantown West Virginia 26506 —
Wheeling Hospital Wheeling West Virginia 26003 —
Aurora BayCare Medical Center Green Bay Wisconsin 54311 —
Wheaton Franciscan Cancer Care-All Saints Racine Wisconsin 53405 —

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 309 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00878709, 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 Jun 11, 2021 · Synced Oct 19, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00878709 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →