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.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00004067
First received: December 10, 1999
Last updated: March 6, 2014
Last verified: March 2014
  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: herceptin
Drug: adriamycin
Drug: cyclophosphamide
Drug: taxol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 (DFS) [ Time Frame: Time from randomization through 5 years ] [ Designated as safety issue: No ]
    Breast cancer recurrence, second primary cancer, death from any cause as first event

  • Cardiotoxicity [ Time Frame: time from randomization through 4 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: time from randomization through 5 years ] [ Designated as safety issue: No ]
    Death from any cause.

  • Long term effect of trastuzumab on cardiac function [ Time Frame: At 5 and 10 years after randomization ] [ Designated as safety issue: Yes ]
    Ejection fraction will be measured by multigated acquisition scan (MUGA).


Enrollment: 2130
Study Start Date: February 2000
Estimated Study Completion Date: March 2014
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: adriamycin + cyclophosphamide then taxol Drug: adriamycin
60 mg/m2 IV push every 21 days for 4 cycles.
Other Name: doxorubicin
Drug: cyclophosphamide
600 mg/m2 IV every 21 days for 4 cycles
Drug: taxol
175 mg/m2 IV every 21 days for 4 cycles
Other Name: paclitaxel
Experimental: Arm 2: adriamycin + cyclophosphamide then taxol + herceptin Biological: herceptin
4 mg/kg loading dose then 2 mg/kg weekly for 1 year.
Other Name: trastuzumab
Drug: adriamycin
60 mg/m2 IV push every 21 days for 4 cycles.
Other Name: doxorubicin
Drug: cyclophosphamide
600 mg/m2 IV every 21 days for 4 cycles
Drug: taxol
175 mg/m2 IV every 21 days for 4 cycles
Other Name: paclitaxel

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 1: 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 2: 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 2) 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

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

Inclusion criteria

  • The patient must have a life expectancy of at least 10 years, excluding her diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)
  • The interval between the last surgery for breast cancer treatment (lumpectomy, mastectomy, axillary dissection, or re-excision of lumpectomy margins) and randomization must be less than or equal to 84 days.
  • All of the following staging criteria must be met:

    • Primary tumor must be T1-3 by clinical and pathologic evaluation.
    • Ipsilateral nodes must be cN0-1 by clinical evaluation.
    • Ipsilateral nodes must be pN1, pN2a, or pN3a by pathologic evaluation.
    • M0
  • Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection. Sentinel node biopsy is permitted, but must be followed by an axillary dissection.
  • The tumor must be invasive adenocarcinoma on histologic examination.
  • The tumor must be determined to be HER2-positive prior to randomization. Assays performed using fluorescent in situ hybridization (FISH) require gene amplification to be eligible. Assays using immunohistochemistry (IHC) must be performed at an NSABP-approved reference laboratory and require a strongly positive staining score.
  • Patients must have an analysis of both estrogen and progesterone receptors performed on the primary tumor prior to randomization. "Marginal," "borderline," etc., results (i.e., those not definitely negative) will also be considered positive regardless of the methodology used.
  • At the time of randomization, the patient must have had the following: history and physical exam, EKG, and PA and lateral chest x-ray within the past 3 months; and a bilateral mammogram (or unilateral if patient has had a mastectomy) and a pelvic exam (for women who have a uterus and who will be taking tamoxifen) within the past year.
  • Within 3 months prior to entry, the patient must have a baseline left ventricular ejection fraction (LVEF) measured by MUGA scan equal to or greater than the lower limit of normal for the radiology facility. (If LVEF is > 75%, the investigator should consider having the LVEF determination reviewed prior to randomization. Following randomization, the LVEF determination may be reviewed up until the time of the post-AC MUGA. Please note that if a more accurate value is obtained from the review of the baseline MUGA, the corrected value must be submitted to the NSABP Biostatistical Center before the post-AC MUGA is performed.)
  • At the time of randomization:

    • The postoperative absolute neutrophil count (ANC) must be ≥ 1500/mm3 (or <1500/mm3 if, in the opinion of the investigator, this represents an ethnic or racial variation of normal).
    • Postoperative platelet count must be ≥ 100,000/mm3. Significant underlying hematologic disorders must be excluded when the platelet count is above the upper limit of normal for the lab.
  • There must be postoperative evidence of adequate hepatic function, i.e., total bilirubin must be ≤ ULN for the lab unless the patient has a chronic grade 1 bilirubin elevation (>ULN to ≤1.5 x ULN) due to Gilbert's disease or similar syndrome; and alkaline phosphatase must be <2.5 times the ULN for the lab; and the serum glutamic-oxaloacetic transaminase (SGOT [AST]) must be <1.5 times the ULN for the lab.
  • There must be postoperative evidence of adequate renal function (serum creatinine within or less than the institution's normal range).
  • Patients must have no clinical or radiologic evidence of metastatic disease. Suspicious findings must be confirmed as benign by radiologic evaluation or biopsy. A patient with skeletal pain is eligible for inclusion in the study if bone scan and/or roentgenological examination fails to disclose metastatic disease.
  • Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  • Prior to randomization, the investigator must designate whether the patients who had a lumpectomy will receive local or locoregional radiation therapy. For patients who had a mastectomy, the investigator must designate whether or not the patient will receive radiation therapy. (Pre-randomization discussion and/or consultation with a radiation oncologist is encouraged.) Note: Irradiation of any internal mammary nodes is prohibited in this trial.
  • Special conditions for eligibility of lumpectomy patients: irradiation and surgery
  • Patients treated by lumpectomy and axillary node dissection to be followed by breast radiation therapy must meet all the eligibility criteria in addition to the following: Generally, lumpectomy should be reserved for tumors <5 cm. However, at the investigator's discretion, patients treated with lumpectomy for tumors ≥ 5 cm are eligible. The margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. In patients in whom pathologic examination demonstrates tumor present at the line of resection, additional operative procedures may be performed to obtain clear margins. This is permissible even if axillary dissection has been performed. Patients in whom tumor is still present at the resected margin after re-excision(s) must undergo total mastectomy to be eligible. Whole breast irradiation is required. Irradiation of regional lymph nodes is optional, but partial breast irradiation and irradiation of any internal mammary nodes are prohibited in this trial. Intent to irradiate the axilla or other regional node groups must be declared by the investigator prior to randomization for stratification purposes.
  • Special conditions for eligibility of mastectomy patients: irradiation. The decision to use locoregional irradiation in patients who have undergone total mastectomy and axillary node dissection must be declared by the investigator prior to randomization for stratification purposes. Failure to adhere to the radiation therapy plan will be a protocol violation.

Exclusion criteria

  • Bilateral malignancy or a mass or mammographic abnormality in the opposite breast suspicious for malignancy unless there is biopsy proof that the mass is not malignant.
  • Primary tumor staged as T4 for any reason.
  • Nodes staged as clinical N2 or N3 for any reason and nodes staged as pathologic pN2b, pN3b, or pN3c.
  • Prior history of breast cancer, including DCIS (patients with a history of lobular carcinoma in situ [LCIS] are eligible).
  • Treatment including radiation therapy, chemotherapy, biotherapy, and/or hormonal therapy administered for the currently diagnosed breast cancer prior to randomization. The only exception is hormonal therapy, which may have been given for up to a total of 28 days anytime after diagnosis and before randomization. In such a case, hormonal therapy must stop at or before randomization and be re-started if indicated following chemotherapy.
  • Prior anthracycline or taxane therapy for any malignancy.
  • Any sex hormonal therapy, e.g., birth control pills, ovarian hormonal replacement therapy, etc. (These patients are eligible only if this therapy is discontinued prior to randomization.)
  • Therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or prevention. (Patients are eligible only if these medications are discontinued prior to randomization. These medications are not permitted while on the study except for the use of tamoxifen as described in the protocol)
  • Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude a patient from being subjected to any of the treatment options or would prevent prolonged follow-up.
  • Cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin. This includes:
  • Active cardiac disease:

    • angina pectoris that requires the use of antianginal medication;
    • cardiac arrhythmia requiring medication;
    • severe conduction abnormality;
    • clinically significant valvular disease;
    • cardiomegaly on chest x-ray;
    • ventricular hypertrophy on EKG; or
    • patients with poorly controlled hypertension, i.e., diastolic greater than 100 mm/Hg. (Patients with hypertension who are well controlled on medication are eligible for entry.)
  • History of cardiac disease:

    • myocardial infarction documented as a clinical diagnosis or by EKG or any other tests;
    • documented congestive heart failure; or
    • documented cardiomyopathy.
  • Psychiatric or addictive disorders that would preclude obtaining informed consent.
  • Pregnancy or lactation at the time of proposed randomization. This protocol excludes pregnant or lactating women based on the fetal toxicity of both tamoxifen and Taxol which are listed as Pregnancy Category D agents. Pregnant women who received tamoxifen have experienced fetal deaths, birth defects, spontaneous abortions, and vaginal bleeding. Women of reproductive potential must agree to use an effective barrier method of contraception. Hormonal birth control methods are not permitted.
  • Sensory/motor neuropathy ≥ grade 2, as defined by the NCI's Common Toxicity Criteria version 2.0.
  • Contraindications to corticosteroid use which, in the opinion of the investigator, would preclude participation in this study.
  • Concurrent treatment with other investigational agents.
  • Sensitivity to benzyl alcohol.
  • Special conditions for ineligibility of lumpectomy patients: irradiation and surgery. For patients treated by lumpectomy with axillary dissection, breast irradiation is required. Please see guidelines for radiation therapy in Appendix A. In addition, the following patients will also be ineligible:

    • Patients with diffuse tumors (as demonstrated on mammography) that would not be considered surgically amenable to lumpectomy.
    • Patients treated with lumpectomy in whom there is another clinically dominant mass or mammographically suspicious abnormality within the ipsilateral breast remnant. Such a mass must be biopsied and demonstrated to be histologically benign prior to randomization or, if malignant, must be surgically removed with clear margins.
    • Patients in whom the margins of the resected specimen are involved with invasive tumor or ductal carcinoma in situ (DCIS). Additional surgical resections to obtain free margins are allowed. Patients in whom tumor is still present after the additional resection(s) must undergo mastectomy to be eligible.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Scripps Cancer Center at Scripps Clinic
La Jolla, California, United States, 92037
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
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262
Sutter Cancer Center
Sacramento, California, United States, 95816
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States, 95403
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, United States, 94589
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
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States, 33140
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806
Cancer Research Network, Inc.
Plantation, Florida, United States, 33324
Florida Cancer Specialists
Sarasota, Florida, United States, 34236
United States, Georgia
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
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
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States, 60612
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
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
West Suburban Hospital Medical Center
Oak Park, Illinois, United States, 60302
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367
Community Hospital
Munster, Indiana, United States, 46321
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
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
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0093
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
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
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Berkshire Medical Center
Pittsfield, Massachusetts, United States, 01201
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
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
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075-9975
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110-0250
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
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
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
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
New York Oncology Hematology, P.C. at Albany Regional Cancer Care
Albany, New York, United States, 12208
Lincoln Medical and Mental Health Center
Bronx, New York, United States, 10451
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, United States, 10305
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
United States, North Carolina
Alamance Cancer Center
Burlington, North Carolina, United States, 27216
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, United States, 27858-4354
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
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
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0502
Cancer Center at Jewish Hospital
Cincinnati, Ohio, United States, 45236
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
CCOP - Columbus
Columbus, Ohio, United States, 43206
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
CCOP - Dayton
Kettering, Ohio, United States, 45429
Cancer Care Center at Northside Medical Center
Youngstown, Ohio, United States, 44501
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
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213-3489
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
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
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Baylor College of Medicine
Houston, Texas, United States, 77030
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410-1894
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
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
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
MBCCOP - Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
Puget Sound Oncology Consortium
Seattle, Washington, United States, 98109
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, West Virginia
David Lee Cancer Center at Charleston Area Medical Center
Charleston, West Virginia, United States, 25304-1297
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Oncology Alliance, S.C. - Milwaukee
Milwaukee, Wisconsin, United States, 53211-2906
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
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
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
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
Hopital du Saint-Sacrement, Quebec
Quebec City, Quebec, Canada, G1S 4L8
Sponsors and Collaborators
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation, Inc.
  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.
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.
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.
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.
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier: NCT00004067     History of Changes
Other Study ID Numbers: NSABP B-31, CDR0000067269
Study First Received: December 10, 1999
Last Updated: March 6, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Surgical Adjuvant Breast and Bowel Project (NSABP):
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Trastuzumab
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 29, 2014