Doxorubicin and Cyclophosphamide Plus Paclitaxel With or Without Trastuzumab in Treating Women With Node-Positive Breast Cancer That Overexpresses HER2
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
2 other identifiers
interventional
2,130
2 countries
149
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Feb 2000
Longer than P75 for phase_3 breast-cancer
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 1999
CompletedStudy Start
First participant enrolled
February 1, 2000
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedApril 29, 2021
April 1, 2021
5.1 years
December 10, 1999
April 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Disease Free Survival (DFS)
Breast cancer recurrence, second primary cancer, death from any cause as first event
Time from randomization through 5 years
Cardiotoxicity
time from randomization through 4 months
Secondary Outcomes (2)
Survival
time from randomization through 5 years
Long term effect of trastuzumab on cardiac function
At 5 and 10 years after randomization
Study Arms (2)
Arm 1: adriamycin + cyclophosphamide then taxol
ACTIVE COMPARATORArm 2: adriamycin + cyclophosphamide then taxol + herceptin
EXPERIMENTALInterventions
4 mg/kg loading dose then 2 mg/kg weekly for 1 year.
60 mg/m2 IV push every 21 days for 4 cycles.
600 mg/m2 IV every 21 days for 4 cycles
175 mg/m2 IV every 21 days for 4 cycles
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +7 more criteria
You may not qualify if:
- 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;
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NSABP Foundation Inclead
- National Cancer Institute (NCI)collaborator
Study Sites (149)
Comprehensive Cancer Institute
Huntsville, Alabama, 35801, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99519-6604, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, 85006-2726, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
Sutter Health Western Division Cancer Research Group
Greenbrae, California, 94904, United States
Scripps Cancer Center at Scripps Clinic
La Jolla, California, 92037, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Pacific Shores Medical Group Comprehensive Hematology-Oncology Services - Long Beach
Long Beach, California, 90813, United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, 92868, United States
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262, United States
Sutter Cancer Center
Sacramento, California, 95816, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, 92120, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80010, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, 80209-5031, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, 06360-7106, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, 06102-5037, United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899, United States
Morton Plant Hospital
Clearwater, Florida, 33756, United States
Halifax Medical Center
Daytona Beach, Florida, 32114, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, 32806, United States
Cancer Research Network, Inc.
Plantation, Florida, 33324, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Phoebe Cancer Center at Phoebe Putney Memorial Hospital
Albany, Georgia, 31701, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701, United States
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, 30912-4000, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
North Idaho Cancer Center
Coeur d'Alene, Idaho, 83814, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-9985, United States
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, 60612, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
CCOP - Central Illinois
Decatur, Illinois, 62526, United States
CCOP - Evanston
Evanston, Illinois, 60201, United States
West Suburban Hospital Medical Center
Oak Park, Illinois, 60302, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602, United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801, United States
Methodist Cancer Center at Methodist Hospital
Indianapolis, Indiana, 46206-1367, United States
Community Hospital
Munster, Indiana, 46321, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1009, United States
CCOP - Wichita
Wichita, Kansas, 67214-3882, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0093, United States
Norton Cancer Center at Norton Hospital
Louisville, Kentucky, 40202-5070, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
New Orleans, Louisiana, 70112, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, 04401, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
National Naval Medical Center
Bethesda, Maryland, 20889-5000, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118, United States
Berkshire Medical Center
Pittsfield, Massachusetts, 01201, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, 01199, United States
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, 01655, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202, United States
Michigan State University
East Lansing, Michigan, 48824, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, 48075-9975, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807, United States
Saint Louis University Cancer Center
St Louis, Missouri, 63110-0250, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, 68114, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131, United States
New York Oncology Hematology, P.C. at Albany Regional Cancer Care
Albany, New York, 12208, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, 12801, United States
Nalitt Cancer Institute at Staten Island University Hospital
Staten Island, New York, 10305, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451, United States
MBCCOP-Our Lady of Mercy Cancer Center
The Bronx, New York, 10466, United States
Alamance Cancer Center
Burlington, North Carolina, 27216, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
Greenville, North Carolina, 27858-4354, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, 27104-4241, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122, United States
Akron City Hospital at Summa Health System
Akron, Ohio, 44309, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, 44710, United States
Cancer Center at Jewish Hospital
Cincinnati, Ohio, 45236, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0502, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, 44106-5065, United States
South Pointe Hospital Cancer Care Center
Cleveland, Ohio, 44122, United States
CCOP - Columbus
Columbus, Ohio, 43206, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240, United States
CCOP - Dayton
Kettering, Ohio, 45429, United States
Cancer Care Center at Northside Medical Center
Youngstown, Ohio, 44501, United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97213, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489, United States
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, 18501, United States
York Cancer Center at Wellspan Health
York, Pennsylvania, 17315, United States
Kent County Memorial Hospital
Warwick, Rhode Island, 02886, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104, United States
Medical City Dallas Hospital
Dallas, Texas, 75230, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811, United States
CCOP - Scott and White Hospital
Temple, Texas, 76508, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05405-0075, United States
Sentara Cancer Institute at Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Puget Sound Oncology Consortium
Seattle, Washington, 98109, United States
CCOP - Northwest
Tacoma, Washington, 98405-0986, United States
David Lee Cancer Center at Charleston Area Medical Center
Charleston, West Virginia, 25304-1297, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102, United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-3508, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
Oncology Alliance, S.C. - Milwaukee
Milwaukee, Wisconsin, 53211-2906, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4M1, Canada
Royal Victoria Hospital - Montreal
Montreal, Quebec, H3A 1A1, Canada
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Jewish General Hospital - Montreal
Montreal, Quebec, H3T 1E2, Canada
St. Mary's Hospital Center
Montreal, Quebec, H3T 1M5, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, G1S 4L8, Canada
Related Publications (28)
Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33. doi: 10.3816/CBC.2008.n.037.
PMID: 18757259BACKGROUNDReinholz 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.
BACKGROUNDGarrison 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 Aug 1;110(3):489-98. doi: 10.1002/cncr.22806.
PMID: 17592827BACKGROUNDKurian 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. doi: 10.1200/JCO.2006.06.3081.
PMID: 17308268BACKGROUNDLiberato 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. doi: 10.1200/JCO.2006.06.4220.
PMID: 17308267BACKGROUNDPerez 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.
BACKGROUNDTelli 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. doi: 10.1200/JCO.2007.11.0106.
PMID: 17687157BACKGROUNDBaselga 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. doi: 10.1634/theoncologist.11-90001-4.
PMID: 16971734BACKGROUNDGupta 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.
BACKGROUNDBurstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med. 2005 Oct 20;353(16):1652-4. doi: 10.1056/NEJMp058197. No abstract available.
PMID: 16236735BACKGROUNDHortobagyi GN. Trastuzumab in the treatment of breast cancer. N Engl J Med. 2005 Oct 20;353(16):1734-6. doi: 10.1056/NEJMe058196. No abstract available.
PMID: 16236745BACKGROUNDTan-Chiu E, Piccart M. Moving forward: Herceptin in the adjuvant setting. Oncology. 2002;63 Suppl 1:57-63. doi: 10.1159/000066201.
PMID: 12422056BACKGROUNDCosta RB, Kurra G, Greenberg L, Geyer CE. Efficacy and cardiac safety of adjuvant trastuzumab-based chemotherapy regimens for HER2-positive early breast cancer. Ann Oncol. 2010 Nov;21(11):2153-2160. doi: 10.1093/annonc/mdq096. Epub 2010 Mar 29.
PMID: 20351072BACKGROUNDRastogi 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.
RESULTGeyer 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.
RESULTKim 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.
RESULTTan-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. doi: 10.1200/JCO.2005.02.4091.
PMID: 16258083RESULTGeyer 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.
RESULTPaik 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--National Surgical Adjuvant Breast and Bowel Project experience. J Natl Cancer Inst. 2002 Jun 5;94(11):852-4. doi: 10.1093/jnci/94.11.852.
PMID: 12048273RESULTRomond 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. doi: 10.1056/NEJMoa052122.
PMID: 16236738RESULTPerez EA, Romond EH, Suman VJ, Jeong JH, Davidson NE, Geyer CE Jr, Martino S, Mamounas EP, Kaufman PA, Wolmark N. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011 Sep 1;29(25):3366-73. doi: 10.1200/JCO.2011.35.0868. Epub 2011 Jul 18.
PMID: 21768458RESULTChumsri S, Pai T, Ma Y, Li Z, Gil A, Moreno-Aspitia A, Colon-Otero G, Pogue-Geile KL, Rasgoti P, Paik S, Perez EA, Thompson EA. Clinical Treatment Score Post-5 Years (CTS5) and Late Recurrence Risk in Hormone Receptor-Positive, HER2-Positive Breast Cancer. J Natl Compr Canc Netw. 2024 Aug 26;22(7):463-468. doi: 10.6004/jnccn.2024.7015.
PMID: 39191270DERIVEDChumsri S, Li Z, Serie DJ, Mashadi-Hossein A, Colon-Otero G, Song N, Pogue-Geile KL, Gavin PG, Paik S, Moreno-Aspitia A, Perez EA, Thompson EA. Incidence of Late Relapses in Patients With HER2-Positive Breast Cancer Receiving Adjuvant Trastuzumab: Combined Analysis of NCCTG N9831 (Alliance) and NRG Oncology/NSABP B-31. J Clin Oncol. 2019 Dec 10;37(35):3425-3435. doi: 10.1200/JCO.19.00443. Epub 2019 Oct 17.
PMID: 31622131DERIVEDChumsri S, Serie DJ, Li Z, Pogue-Geile KL, Soyano-Muller AE, Mashadi-Hossein A, Warren S, Lou Y, Colon-Otero G, Knutson KL, Perez EA, Moreno-Aspitia A, Thompson EA. Effects of Age and Immune Landscape on Outcome in HER2-Positive Breast Cancer in the NCCTG N9831 (Alliance) and NSABP B-31 (NRG) Trials. Clin Cancer Res. 2019 Jul 15;25(14):4422-4430. doi: 10.1158/1078-0432.CCR-18-2206. Epub 2019 Feb 26.
PMID: 30808774DERIVEDGavin PG, Song N, Kim SR, Lipchik C, Johnson NL, Bandos H, Finnigan M, Rastogi P, Fehrenbacher L, Mamounas EP, Swain SM, Wickerham DL, Geyer CE Jr, Jeong JH, Costantino JP, Wolmark N, Paik S, Pogue-Geile KL. Association of Polymorphisms in FCGR2A and FCGR3A With Degree of Trastuzumab Benefit in the Adjuvant Treatment of ERBB2/HER2-Positive Breast Cancer: Analysis of the NSABP B-31 Trial. JAMA Oncol. 2017 Mar 1;3(3):335-341. doi: 10.1001/jamaoncol.2016.4884.
PMID: 27812689DERIVEDO'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors </= 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.
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PMID: 22987084DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Wolmark, MD
NSABP Foundation Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 1999
First Posted
January 27, 2003
Study Start
February 1, 2000
Primary Completion
March 1, 2005
Study Completion
November 1, 2019
Last Updated
April 29, 2021
Record last verified: 2021-04