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Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
This study is ongoing, but not recruiting participants.
First Received: July 5, 2000   Last Updated: October 29, 2009   History of Changes
Sponsor: North Central Cancer Treatment Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Southwest Oncology Group
NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005970
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether combination chemotherapy is more effective with or without trastuzumab in treating breast cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and trastuzumab to see how well they work compared to combination chemotherapy alone in treating women with breast cancer.


Condition Intervention Phase
Breast Cancer
Biological: trastuzumab
Drug: aromatase inhibition therapy
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing Node Positive or High-Risk Node Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2000
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed operable adenocarcinoma of the breast, meeting 1 of the following criteria:

    • Node-positive disease, meeting the following criteria:

      • One or more positive lymph nodes (T1-3, pN1-2, M0)
      • No cN2 disease
      • pN2 disease allowed
      • One positive lymph node by sentinel node biopsy or at least 6 axillary nodes must be examined on axillary node dissection with at least 1 positive lymph node
      • Metaplastic carcinoma allowed
    • High-risk node-negative disease, meeting the following criteria:

      • Node-negative as determined by 1 of the following:

        • Negative sentinel node biopsy
        • No positive lymph nodes found among at least 6 axillary nodes examined on axillary node dissection
      • Tumor must be greater than 2.0 cm if estrogen-receptor (ER)- and progesterone-receptor (PR)-positive disease is present OR greater than 1.0 cm if ER and PR negative NOTE: Lymph nodes positive by immunohistochemistry (IHC) only are not considered positive nodes
  • HER-2 positive

    • Fluorescent in situ hybridization (FISH) must show gene amplification OR
    • IHC assay must show a strong positive (3+) staining score
    • Ductal carcinoma in situ (DCIS) components must not be counted in determination of the degree of IHC staining or FISH amplification
  • No locally advanced (T4) tumors at diagnosis, including:

    • Tumors fixed to chest wall
    • Peau d'orange
    • Skin ulcerations/nodules
    • Clinical inflammatory changes (diffuse brawny cutaneous induration with an erysipeloid edge)
  • No bilateral invasive carcinoma or DCIS (metachronous or synchronous)

    • Unilateral invasive carcinoma and previous metachronous or synchronous DCIS of the contralateral breast treated with mastectomy allowed
  • No prior breast cancer except lobular carcinoma in situ (LCIS)
  • No more than 84 days since prior mastectomy or axillary or sentinel node dissection

    • No gross or microscopic disease at margins
  • No significant pericardial effusion
  • Hormone receptor status:

    • ER/PR status known

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Any status

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST no greater than 2 times ULN

Renal:

  • Not specified

Cardiovascular:

  • LVEF normal
  • No prior myocardial infarction or congestive heart failure
  • No prior arrhythmia or cardiovalvular disease that requires medications or is clinically significant
  • No uncontrolled hypertension (diastolic blood pressure [BP] greater than 100 mm Hg and systolic BP greater than 200 mm Hg)

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 2 months after study participation
  • No active unresolved infection
  • No known sensitivity to benzyl alcohol
  • No grade 2 or greater neuropathy
  • No other prior malignancy within the past 5 years except:

    • Effectively treated squamous cell or basal cell skin cancer
    • Carcinoma in situ of the cervix treated with surgery only
    • LCIS of the ipsilateral or contralateral breast treated with surgery and/or tamoxifen only

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy or immunotherapy for breast cancer

Chemotherapy:

  • No prior chemotherapy for breast cancer
  • No prior anthracycline or taxane

Endocrine therapy:

  • Prior tamoxifen or any other hormonal therapy for breast cancer allowed if administered for no more than 4 weeks
  • Prior tamoxifen or raloxifene for chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (e.g., prior LCIS) allowed
  • No concurrent tamoxifen or raloxifene
  • No concurrent hormonal therapy (e.g., birth control pills or hormone replacement therapy)

Radiotherapy:

  • No prior radiotherapy for breast cancer

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent digitalis or beta-blockers for congestive heart failure
  • No concurrent medications for cardiac arrhythmias or angina pectoris
  • No concurrent cardioprotective drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005970

  Hide Study Locations
Locations
United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36607
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36207
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99519-6604
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States, 85012
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Veterans Affairs Medical Center - Little Rock
Little Rock, Arkansas, United States, 72205
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Naval Medical Center - San Diego
San Diego, California, United States, 92134-3202
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
University of California Davis Cancer Center
Sacramento, California, United States, 95817
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305-5216
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, United States, 92357
Veterans Affairs Medical Center - San Diego
San Diego, California, United States, 92161
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States, 94553
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
United States, Delaware
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
Veterans Affairs Medical Center - Washington, DC
Washington, District of Columbia, United States, 20422
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0277
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
Martin Memorial Cancer Center
Stuart, Florida, United States, 34994
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States, 33021
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States, 33612
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153-5500
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
La Grange Oncology Associates
La Grange, Illinois, United States, 60525
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Veterans Affairs Medical Center - Chicago Westside Hospital
Chicago, Illinois, United States, 60612
Veterans Affairs Medical Center - Hines
Hines, Illinois, United States, 60141
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Fort Wayne Medical Oncology and Hematology, Incorporated
Fort Wayne, Indiana, United States, 46885-5099
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101-1733
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States, 67218
United States, Kentucky
Baptist Hospital East - Louisville
Louisville, Kentucky, United States, 40207
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0084
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States, 40502-2236
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States, 71101-4295
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Cancer Center at Tufts - New England Medical Center
Boston, Massachusetts, United States, 02111
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
Saint Joseph, Michigan, United States, 49085
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0948
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201-1932
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States, 39216
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, United States, 65201
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7680
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital
Camden, New Jersey, United States, 08103
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
United States, New Mexico
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States, 87131
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States, 87108-5138
United States, New York
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Mount Sinai Medical Center
New York, New York, United States, 10029
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Lipson Cancer and Blood Center at Rochester General Hospital
Rochester, New York, United States, 14621
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
North Shore University Hospital
Manhasset, New York, United States, 11030
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, United States, 14215
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, United States, 13210
United States, North Carolina
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States, 28302-2000
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Comprehensive Cancer Center at Moore Regional Hospital
Pinehurst, North Carolina, United States, 28374
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28503-1678
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
NorthEast Oncology Associates - Concord
Concord, North Carolina, United States, 28025
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, United States, 28805-9913
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402-9025
United States, North Dakota
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Medcenter One Health System
Bismarck, North Dakota, United States, 58501-5505
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0501
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-9001
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220-2288
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428-1002
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States, 17822-2001
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States, 17110
United States, Rhode Island
Miriam Hospital at Lifespan
Providence, Rhode Island, United States, 02906
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
CCOP - Greenville
Greenville, South Carolina, United States, 29615
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States, 29401-5799
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
United States, Tennessee
University of Tennessee Cancer Institute at Methodist Central Hospital
Memphis, Tennessee, United States, 38104
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-6307
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234-6200
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Harrington Cancer Center
Amarillo, Texas, United States, 79106
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4095
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States, 79106
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0565
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - Temple
Temple, Texas, United States, 76504
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112-5550
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Care Center at Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22902
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
Roanoke, Virginia, United States, 24014
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, United States, 23502
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States, 98108
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
United States, West Virginia
St. Mary's Medical Center
Huntington, West Virginia, United States, 25701
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Peru
Instituto de Enfermedades Neoplasicas
Lima, Peru, 34
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Sponsors and Collaborators
North Central Cancer Treatment Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Southwest Oncology Group
NCIC Clinical Trials Group
Investigators
Study Chair: Edith A. Perez, MD Mayo Clinic
Study Chair: Nancy E. Davidson, MD Sidney Kimmel Comprehensive Cancer Center
Study Chair: Peter A. Kaufman, MD Norris Cotton Cancer Center
Study Chair: Silvana Martino, DO John Wayne Cancer Institute at Saint John's Health Center
Study Chair: Karen A. Gelmon, MD British Columbia Cancer Agency
  More Information

Additional Information:
Publications:
Halyard MY, Pisansky TM, Dueck AC, Suman V, Pierce L, Solin L, Marks L, Davidson N, Martino S, Kaufman P, Kutteh L, Dakhil SR, Perez EA. Radiotherapy and Adjuvant Trastuzumab in Operable Breast Cancer: Tolerability and Adverse Event Data From the NCCTG Phase III Trial N9831. J Clin Oncol. 2009 Apr 6; [Epub ahead of print]
Moreno-Aspitia A, Hillman DW, Dueck AC, et al.: Baseline and recurrence levels of soluble HER2 (sHER2) in early-stage HER2-neu positive breast cancer (HER2+BC) from the NCCTG adjuvant Intergroup trial N9831. [Abstract] J Clin Oncol 27 (Suppl 15): A-539, 2009.
Moreno-Aspitia A, Dueck AC, Lingle WL, et al.: Serum HER2 (sHER2) levels in early-stage HER2 neu (+) breast cancer (HER2+BC): results from the NCCTG adjuvant Intergroup trial N9831. [Abstract] J Clin Oncol 26 (Suppl 15): A-529, 2008.
Perez EA, Reinholz MM, Dueck AC, et al.: c-MYC amplification and correlation with patient outcome in early stage HER2+ breast cancer from the NCCTG adjuvant intergroup trial N9831. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-56, 2008.
Perez EA, Suman VJ, Davidson NE, Sledge GW, Kaufman PA, Hudis CA, Martino S, Gralow JR, Dakhil SR, Ingle JN, Winer EP, Gelmon KA, Gersh BJ, Jaffe AS, Rodeheffer RJ. Cardiac Safety Analysis of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With or Without Trastuzumab in the North Central Cancer Treatment Group N9831 Adjuvant Breast Cancer Trial. J Clin Oncol. 2008 Feb 4; [Epub ahead of print]
Kutteh LA, Hobday T, Jaffe A, et al.: A correlative study of cardiac biomarkers and left ventricular ejection fraction (LVEF) from N9831, a phase III randomized trial of chemotherapy and trastuzumab as adjuvant therapy for HER2-positive breast cancer. [Abstract] J Clin Oncol 25 (Suppl 18): A-579, 2007.
Reinholz MM, Jenkins RB, Hillman D, et al.: The clinical significance of polysomy 17 in the HER2+ N9831 intergroup adjuvant trastuzumab trial. [Abstract] Breast Cancer Res Treat 106 (1): A-36, S11, 2007.
Halyard MY, Pisansky TM, Solin LJ, et al.: Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: toxicity data from North Central Cancer Treatment Group phase III trial N9831. [Abstract] J Clin Oncol 24 (Suppl 18): A-523, 2006.
Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, Flynn PJ, Ingle JN, Visscher D, Jenkins RB. HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. J Clin Oncol. 2006 Jul 1;24(19):3032-8.
Miller DV, Jenkins RB, Lingle WL, et al.: Focal HER2/neu amplified clones partially account for discordance between immunohistochemistry and fluorescence in-situ hybridization results: data from NCCTG N9831 intergroup adjuvant trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-568, 19s, 2004.
Perez EA, Suman VJ, Davidson NE, et al.: HER2 testing by local, central, and reference laboratories in the NCCTG N9831 intergroup adjuvant trial. [Abstract] J Clin Oncol 22 (Suppl 14): A-567, 19s, 2004.
Perez EA, Suman VJ, Davidson NE, Kaufman PA, Martino S, Dakhil SR, Ingle JN, Rodeheffer RJ, Gersh BJ, Jaffe AS. Effect of doxorubicin plus cyclophosphamide on left ventricular ejection fraction in patients with breast cancer in the North Central Cancer Treatment Group N9831 Intergroup Adjuvant Trial. J Clin Oncol. 2004 Sep 15;22(18):3700-4.
Perez EA, Suman VJ, Davidson NE, et al.: Effect of doxorubicin plus cyclophosphamide (AC) on left ventricular ejection fraction (LVEF) in the NCCTG N9831 intergroup adjuvant trial. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-75, 19, 2003.
Roche PC, Suman VJ, Jenkins RB, Davidson NE, Martino S, Kaufman PA, Addo FK, Murphy B, Ingle JN, Perez EA. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst. 2002 Jun 5;94(11):855-7.
Partridge AH, Wolff AC, Marcom PK, Kaufman PA, Zhang L, Gelman R, Moore C, Lake D, Fleming GF, Rugo HS, Atkins J, Sampson E, Collyar D, Winer EP. The impact of sharing results of a randomized breast cancer clinical trial with study participants. Breast Cancer Res Treat. 2008 Jun 10; [Epub ahead of print]
Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33.
Reinholz MM, Dueck AC, Lingle WL, et al.: The concordance between NCCTG's and NSABP's C-myc FISH assays. [Abstract] J Clin Oncol 26 (Suppl 15): A-22110, 2008.
Garrison LP Jr, Lubeck D, Lalla D, Paton V, Dueck A, Perez EA. Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer. 2007 Jun 25; [Epub ahead of print]
Kurian AW, Thompson RN, Gaw AF, Arai S, Ortiz R, Garber AM. A cost-effectiveness analysis of adjuvant trastuzumab regimens in early HER2/neu-positive breast cancer. J Clin Oncol. 2007 Feb 20;25(6):634-41.
Liberato NL, Marchetti M, Barosi G. Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2007 Feb 20;25(6):625-33.
Perez E, Romond E, Suman V, et al.: Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patiens with HER2-positive breast cancer. [Abstract] J Clin Oncol 25 (Suppl 18): 512, 6s, 2007.
Telli ML, Hunt SA, Carlson RW, Guardino AE. Trastuzumab-related cardiotoxicity: calling into question the concept of reversibility. J Clin Oncol. 2007 Aug 10;25(23):3525-33.
Baselga J, Perez EA, Pienkowski T, Bell R. Adjuvant trastuzumab: a milestone in the treatment of HER-2-positive early breast cancer. Oncologist. 2006;11 Suppl 1:4-12. Review.
Garrison LP, Perez EA, Dueck A, et al.: Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2+ breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-6023, 306s, 2006.
Gupta AK, Mekan SF, Eckman MH: Trastuzumab for all? A decision analysis examining tradeoffs between efficacy and cardiac toxicity of adjuvant therapy in HER2 positive breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-6022, 306s, 2006.
Romond EH, Perez EA, Bryant J, Suman VJ, Geyer CE Jr, Davidson NE, Tan-Chiu E, Martino S, Paik S, Kaufman PA, Swain SM, Pisansky TM, Fehrenbacher L, Kutteh LA, Vogel VG, Visscher DW, Yothers G, Jenkins RB, Brown AM, Dakhil SR, Mamounas EP, Lingle WL, Klein PM, Ingle JN, Wolmark N. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1673-84.
Perez EA, Rodeheffer R. Clinical cardiac tolerability of trastuzumab. J Clin Oncol. 2004 Jan 15;22(2):322-9. Review.

Study ID Numbers: CDR0000067953, NCCTG-N9831, CALGB-49909, ECOG-N9831, SWOG-N9831, GUMC-00224, CAN-NCIC-MA28
Study First Received: July 5, 2000
Last Updated: October 29, 2009
ClinicalTrials.gov Identifier: NCT00005970     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Cyclophosphamide
Antibiotics, Antineoplastic
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Neoplasms by Site
Therapeutic Uses
Trastuzumab
Alkylating Agents
Breast Diseases
Estrogen Antagonists
Skin Diseases
Antineoplastic Agents, Hormonal
Mitosis Modulators
Adjuvants, Immunologic
Breast Neoplasms
Antimitotic Agents
Tamoxifen
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Paclitaxel
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2009