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Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2
This study is ongoing, but not recruiting participants.
First Received: December 10, 1999   Last Updated: August 7, 2009   History of Changes
Sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborator: National Cancer Institute (NCI)
Information provided by: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT00004067
  Purpose

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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 plus trastuzumab is more effective than combination chemotherapy alone for treating breast cancer.

PURPOSE: This randomized phase III trial is studying how well giving combination chemotherapy together with trastuzumab works compared to combination chemotherapy alone in treating women with node-positive stage II or stage IIIA breast cancer that overexpresses HER2.


Condition Intervention Phase
Breast Cancer
Biological: trastuzumab
Drug: AC-T regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: endocrine-modulating drug therapy
Drug: paclitaxel
Drug: tamoxifen citrate
Radiation: radiation therapy
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol (AC-T) to That of Adriamycin and Cyclophosphamide Followed by Taxol Plus Herceptin (AC-T+H) in Node-Positive Breast Cancer Patients Who Have Tumors That Overexpress HER2

Resource links provided by NLM:


Further study details as provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):

Primary Outcome Measures:
  • Disease Free Survival

Secondary Outcome Measures:
  • Survival

Enrollment: 2130
Study Start Date: February 2000
Estimated Study Completion Date: March 2013
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the cardiotoxicity of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®) in women with operable, node-positive breast cancer that overexpresses HER2.
  • Compare the effect of these regimens on disease-free and overall survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to number of positive nodes (1-3 vs 4-9 vs 10 or more), administration of hormonal therapy (tamoxifen vs anastrozole vs neither), surgery/radiotherapy (lumpectomy plus breast irradiation vs lumpectomy plus breast irradiation plus regional irradiation vs mastectomy without radiotherapy vs mastectomy with radiotherapy), paclitaxel schedule (every 3 weeks vs weekly), and participating center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. Approximately 3 weeks after the last course, patients receive paclitaxel IV over 3 hours every 21 days for 4 courses OR paclitaxel IV over 1 hour once weekly for 12 weeks (12 doses).
  • Arm II: Patients receive chemotherapy as in arm I and trastuzumab (Herceptin®) IV over 90 minutes on day 1 of the first course of paclitaxel. Trastuzumab is then administered IV over 30 minutes weekly for 51 weeks, beginning on day 8.

All patients with estrogen or progesterone receptor-positive tumors receive hormonal therapy* for at least 5 years, beginning within 3-12 weeks after the last dose of chemotherapy. Patients who have received prior tamoxifen for prevention may be treated with additional tamoxifen for no more than 5 years at the discretion of the principal investigator (PI).

NOTE: *Other hormonal therapeutic agents are allowed in sequence with or as an alternative to tamoxifen therapy.

All patients previously treated with lumpectomy undergo breast irradiation beginning after completion of chemotherapy and concurrently with trastuzumab (in arm II) administration. Patients previously treated with mastectomy may also receive radiotherapy. Radiotherapy is administered daily for 5-6 weeks.

Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,700 patients will be accrued for this study within 4.75 years.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven invasive adenocarcinoma of the breast

    • Stage IIA, IIB, or IIIA
    • Confined to the breast and ipsilateral axilla (cN0-1) on clinical examination
    • At least 1 histologically positive axillary node
    • No lymph nodes clinically fixed to each other or to other structures (cN2)
    • HER2 strongly positive (3+ by immunostain OR gene amplification by fluorescent in situ hybridization)

      • Submission of tumor block required
  • Must have undergone axillary dissection and either total mastectomy OR lumpectomy

    • Sentinel node dissection allowed, if followed by axillary dissection
    • No diffuse tumors by mammography in patients treated with lumpectomy
    • No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins)
  • No bilateral malignancy, contralateral mass, or mammographic abnormality unless histologically proven as benign
  • No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes unless histologically proven not to be involved with tumor
  • No primary T4 tumors (for any reason)
  • No prior breast cancer, including ductal carcinoma in situ

    • Prior lobular carcinoma in situ allowed
  • Bone pain allowed provided there is no metastatic disease by x-ray, MRI, or biopsy
  • Hormone receptor status:

    • Estrogen and progesterone status known

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • At least 10 years, excluding diagnosis of breast cancer

Hematopoietic:

  • Platelet count at least 100,000/mm^3*
  • Absolute neutrophil count at least 1,500/mm^3 (unless determined by the investigator to be normal for ethnic or racial variation) NOTE: *Significant underlying hematologic disorders must be excluded if above upper limit of normal (ULN)

Hepatic:

  • Bilirubin no greater than ULN
  • SGOT less than 1.5 times ULN
  • Alkaline phosphatase less than 2.5 times ULN
  • No systemic hepatic disease that would preclude study participation

Renal:

  • Creatinine normal
  • No systemic renal disease that would preclude study participation

Cardiovascular:

  • LVEF at least lower limit of normal by MUGA
  • No cardiovascular disease that would preclude study participation
  • No angina pectoris requiring treatment
  • No cardiomegaly on chest x-ray
  • No prior myocardial infarction by clinical diagnosis or by EKG or other test
  • No prior congestive heart failure
  • No prior cardiomyopathy
  • No cardiac arrhythmia requiring medication
  • No severe conduction abnormality
  • No clinically significant valvular disease
  • No poorly controlled hypertension (diastolic greater than 100 mm Hg), unless adequately controlled by medication
  • No ventricular hypertrophy on EKG

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective barrier contraception
  • No other prior malignancy within the past 5 years except effectively treated carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer
  • No psychiatric or addictive disorders that would preclude informed consent
  • No sensory or motor neuropathy grade 2 or greater
  • No contraindications to corticosteroids

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for this breast cancer

Chemotherapy:

  • No prior chemotherapy for this breast cancer
  • No prior anthracycline or taxane therapy for any cancer

Endocrine therapy:

  • No prior hormonal therapy for this breast cancer
  • No concurrent hormonal therapy (e.g., birth control pills or ovarian hormone replacement therapy)
  • No concurrent raloxifene or other selective estrogen-receptor modulators

Radiotherapy:

  • No prior radiotherapy for this breast cancer
  • No concurrent radiotherapy to internal mammary nodes
  • No other concurrent radiotherapy except as specified in study

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004067

  Hide Study Locations
Locations
United States, Alabama
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
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
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach
Long Beach, California, United States, 90813
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States, 92037
Sutter Cancer Center
Sacramento, California, United States, 95816
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
United States, Colorado
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80209-5031
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80010
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-7106
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
United States, Delaware
CCOP - Christiana Care Health Services
Wilmington, Delaware, United States, 19899
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Cancer Research Network, Inc.
Plantation, Florida, United States, 33324
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Florida Cancer Specialists
Sarasota, Florida, United States, 34236
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
North Idaho Cancer Center
Coeur d'Alene, Idaho, United States, 83814
United States, Illinois
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States, 60657
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States, 60612-9985
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States, 60612
West Suburban Hospital Medical Center
Oak Park, Illinois, United States, 60302
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Community Hospital
Munster, Indiana, United States, 46321
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0093
Norton Cancer Center at Norton Hospital
Louisville, Kentucky, United States, 40202-5070
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, United States, 70112
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States, 70112
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
United States, Maryland
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5000
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
Berkshire Medical Center
Pittsfield, Massachusetts, United States, 01201
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
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
Michigan State University
East Lansing, Michigan, United States, 48824
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075-9975
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
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
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110-0250
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
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
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
New York Oncology Hematology, P.C. at Albany Regional Cancer Care
Albany, New York, United States, 12208
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, United States, 10305
Lincoln Medical and Mental Health Center
Bronx, New York, United States, 10451
United States, North Carolina
Alamance Cancer Center
Burlington, North Carolina, United States, 27216
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27858-4354
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, North Dakota
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
Akron City Hospital at Summa Health System
Akron, Ohio, United States, 44309
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710
Cancer Care Center at Northside Medical Center
Youngstown, Ohio, United States, 44501
Cancer Center at Jewish Hospital
Cincinnati, Ohio, United States, 45236
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Kettering, Ohio, United States, 45429
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0502
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
South Pointe Hospital Cancer Care Center
Cleveland, Ohio, United States, 44122
United States, Oklahoma
CCOP - Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
York Cancer Center at Wellspan Health
York, Pennsylvania, United States, 17315
United States, Rhode Island
Kent County Memorial Hospital
Warwick, Rhode Island, United States, 02886
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Utah
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0075
United States, Virginia
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
United States, West Virginia
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
David Lee Cancer Center at Charleston Area Medical Center
Charleston, West Virginia, United States, 25304-1297
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Oncology Alliance, S.C. - Milwaukee
Milwaukee, Wisconsin, United States, 53211-2906
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4M1
Hopital du Saint-Sacrement, Quebec
Quebec City, Quebec, Canada, G1S 4L8
St. Mary's Hospital Center
Montreal, Quebec, Canada, H3T 1M5
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada, H3A 1A1
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Study Chair: Edward H. Romond, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Additional Information:
Publications:
Rastogi P, Jeong J, Geyer CE, et al.: Five year update of cardiac dysfunction on NSABP B-31, a randomized trial of sequential doxorubicin/cyclophosphamide (AC)→paclitaxel (T) vs. AC→T with trastuzumab(H). [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA513, 2007.
Geyer CE, Bryant JL, Romond EH, et al.: Update of cardiac dysfunction on NSABP B-31, a randomized trial of sequential doxorubicin/cyclophosphamide (AC)→paclitaxel (T) vs. AC→T with trastuzumab (H). [Abstract] J Clin Oncol 24 (Suppl 18): A-581, 2006.
Kim C, Bryant J, Horne Z, et al.: Trastuzumab sensitivity of breast cancer with co-amplification of HER2 and cMYC suggests pro-apoptotic function of dysregulated cMYC in vivo. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-46, 2005.
Tan-Chiu E, Yothers G, Romond E, Geyer CE Jr, Ewer M, Keefe D, Shannon RP, Swain SM, Brown A, Fehrenbacher L, Vogel VG, Seay TE, Rastogi P, Mamounas EP, Wolmark N, Bryant J. Assessment of cardiac dysfunction in a randomized trial comparing doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab as adjuvant therapy in node-positive, human epidermal growth factor receptor 2-overexpressing breast cancer: NSABP B-31. J Clin Oncol. 2005 Nov 1;23(31):7811-9.
Geyer CE Jr, Bryant J, Romond E: Cardiac safety analysis of the first stage of NSABP B-31, a randomized trial comparing the safety and efficacy of adriamycin® and cyclophosphamide (AC) followed by taxol® to that of AC followed by taxol® plus herceptin® in patients (Pts) with operable, node-positive (N+), HER-2 overexpressing breast cancer (HER2+BC). [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-23, S13, 2003.
Paik S, Bryant J, Tan-Chiu E, Romond E, Hiller W, Park K, Brown A, Yothers G, Anderson S, Smith R, Wickerham DL, Wolmark N. Real-world performance of HER2 testing--ational Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst. 2002 Jun 5;94(11):852-4.
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.
Burstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med. 2005 Oct 20;353(16):1652-4. No abstract available.
Hortobagyi GN. Trastuzumab in the treatment of breast cancer. N Engl J Med. 2005 Oct 20;353(16):1734-6. No abstract available.
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.
Tan-Chiu E, Piccart M. Moving forward: Herceptin in the adjuvant setting. Oncology. 2002;63 Suppl 1:57-63. Review.

Responsible Party: NSABP Foundation, Inc. ( Norman Wolmark, MD )
Study ID Numbers: NSABP B-31, CDR0000067269
Study First Received: December 10, 1999
Last Updated: August 7, 2009
ClinicalTrials.gov Identifier: NCT00004067     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
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
Breast Neoplasms
Antimitotic Agents
Immunosuppressive Agents
Tamoxifen
Doxorubicin
Pharmacologic Actions
Neoplasms
Paclitaxel
Tubulin Modulators
Myeloablative Agonists

ClinicalTrials.gov processed this record on November 27, 2009