- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003782
Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes
A Three-Arm Randomized Trial to Compare Adjuvant Adriamycin and Cyclophosphamide Followed by Taxotere (AC-T); Adriamycin and Taxotere (AT); and Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients With Positive Axillary Lymph Nodes
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving combination chemotherapy after surgery may kill any tumor cells remaining following surgery. It is not yet known which regimen of combination chemotherapy is more effective in treating breast cancer with positive axillary lymph nodes.
PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer with positive axillary lymph nodes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the efficacy of adjuvant doxorubicin, cyclophosphamide, and docetaxel given concurrently vs adjuvant doxorubicin and cyclophosphamide followed by docetaxel, in terms of overall survival and disease-free survival, of women with breast cancer and positive axillary lymph nodes.
- Compare the efficacy of adjuvant doxorubicin and docetaxel vs regimens containing cyclophosphamide in these patients.
- Compare the toxic effects of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens. (Quality of life substudy closed to accrual as of 7/20/01.)
- Compare the differences in amenorrhea in premenopausal women in each treatment arm and its relationship to symptoms, quality of life (quality of life substudy closed to accrual as of 7/20/01), disease-free survival, and overall survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive nodes (1-3 vs 4-9 vs at least 10), sequential tamoxifen or anastrozole administration (yes vs no), and type of prior surgery and radiotherapy plan (mastectomy with no local or regional radiotherapy vs mastectomy with local and/or regional radiotherapy vs lumpectomy with local radiotherapy vs lumpectomy with local and regional radiotherapy). Patients are randomized to one of three treatment arms.
- Arm 1: Patients receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes every 21 days for 4 courses. Three weeks after the last dose of this combination, patients receive docetaxel IV over 1 hour every 21 days for 4 courses.
- Arm 2: Patients receive doxorubicin IV over 15 minutes and docetaxel IV over 1 hour every 21 days for 4 courses.
- Arm 3: Patients receive doxorubicin IV over 15 minutes, cyclophosphamide IV over 30 minutes, and docetaxel IV over 1 hour every 21 days for 4 courses.
Patients in all arms who are estrogen receptor-positive and/or progesterone receptor-positive receive oral tamoxifen daily for 5 years beginning within 3-12 weeks of completion of chemotherapy. Patients who are postmenopausal may receive alternative hormonal therapy at the discretion of the treating physician.
Some patients may receive postmastectomy radiotherapy on SWOG-S9927 or NCIC-MA.20 after recovery from chemotherapy.
Quality of life and menstrual history are assessed before randomization, on day 1 of course 4, and at 6, 12, 18, and 24 months. (Quality of life substudy closed to accrual as of 7/20/01.)
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within 4-5 years.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
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Alberta
-
Calgary, Alberta, Canada, T2N 4N2
- Tom Baker Cancer Center - Calgary
-
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Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- CancerCare Manitoba
-
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Ontario
-
Mississauga, Ontario, Canada, L5M 2N1
- Credit Valley Hospital
-
Ottawa, Ontario, Canada, K1H 1C4
- Ottawa Regional Cancer Centre
-
Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital - Toronto
-
-
Quebec
-
Montreal, Quebec, Canada, H3G 1A4
- Montreal General Hospital
-
Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital - Montreal
-
Montreal, Quebec, Canada, H2L-4M1
- Centre Hospitalier de l'Université de Montréal
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Montreal, Quebec, Canada, H3T 1E2
- Jewish General Hospital - Montreal
-
Montreal, Quebec, Canada, H3T 1M5
- St. Mary's Hospital Center
-
Quebec City, Quebec, Canada, G1S 4L8
- Hopital du Saint-Sacrement, Quebec
-
-
-
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Alabama
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Huntsville, Alabama, United States, 35801
- Comprehensive Cancer Institute
-
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Alaska
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Anchorage, Alaska, United States, 99519-6604
- Providence Alaska Medical Center
-
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Arizona
-
Phoenix, Arizona, United States, 85006-2726
- CCOP - Western Regional, Arizona
-
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California
-
Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
-
Fresno, California, United States, 93720
- California Cancer Center
-
Greenbrae, California, United States, 94904
- Sutter Health Western Division Cancer Research Group
-
La Jolla, California, United States, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
-
La Jolla, California, United States, 92037
- Scripps Cancer Center at Scripps Clinic
-
Loma Linda, California, United States, 92354
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
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Long Beach, California, United States, 90813
- Pacific Shores Medical Group
-
Oakland, California, United States, 94609-3305
- CCOP - Bay Area Tumor Institute
-
Orange, California, United States, 92868
- Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
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Palm Springs, California, United States, 92262
- Comprehensive Cancer Centers of the Desert
-
Palo Alto, California, United States, 94305-5408
- Stanford Cancer Center at Stanford University Medical Center
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Sacramento, California, United States, 95816
- Sutter Cancer Center
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San Diego, California, United States, 92120
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
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San Francisco, California, United States, 94107-1728
- Catholic Healthcare West - Westbay Region
-
Santa Rosa, California, United States, 95403
- CCOP - Santa Rosa Memorial Hospital
-
Vallejo, California, United States, 94589
- Kaiser Permanente Medical Center - Vallejo
-
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Colorado
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Denver, Colorado, United States, 80209-5031
- CCOP - Colorado Cancer Research Program, Incorporated
-
Denver, Colorado, United States, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
-
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Connecticut
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Farmington, Connecticut, United States, 06360-7106
- University of Connecticut Cancer Center at University of Connecticut Health Center
-
Hartford, Connecticut, United States, 06102-5037
- Hartford Hospital
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Delaware
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Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
-
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District of Columbia
-
Washington, District of Columbia, United States, 20060
- MBCCOP - Howard University Cancer Center
-
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Florida
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Clearwater, Florida, United States, 33756
- Morton Plant Hospital
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Daytona Beach, Florida, United States, 32114
- Halifax Medical Center
-
Jacksonville, Florida, United States, 32207
- Baptist Regional Cancer Institute - Jacksonville
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Miami, Florida, United States, 33136
- University of Miami Sylvester Cancer Center
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Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
-
Orlando, Florida, United States, 32806
- MD Anderson Cancer Center Orlando
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Sarasota, Florida, United States, 34239
- Sarasota Memorial Hospital
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Winship Cancer Institute of Emory University
-
Atlanta, Georgia, United States, 30342-1701
- CCOP - Atlanta Regional
-
Augusta, Georgia, United States, 30912-4000
- Medical College of Georgia Comprehensive Cancer Center
-
Fort Gordon, Georgia, United States, 30905-5650
- Dwight David Eisenhower Army Medical Center
-
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Hawaii
-
Honolulu, Hawaii, United States, 96813
- Cancer Research Center of Hawaii
-
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Idaho
-
Coeur d'Alene, Idaho, United States, 83814
- North Idaho Cancer Center
-
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Illinois
-
Chicago, Illinois, United States, 60612
- Rush-Presbyterian-St. Luke's Medical Center
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Chicago, Illinois, United States, 60657
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center
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Chicago, Illinois, United States, 60612-9985
- John H. Stroger, Jr. Hospital of Cook County
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Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
-
Evanston, Illinois, United States, 60201
- CCOP - Evanston
-
Peoria, Illinois, United States, 61602
- CCOP - Illinois Oncology Research Association
-
Urbana, Illinois, United States, 61801
- CCOP - Carle Cancer Center
-
-
Indiana
-
Indianapolis, Indiana, United States, 46260
- St. Vincent Hospital and Health Care Center
-
Indianapolis, Indiana, United States, 46206-1367
- Methodist Cancer Center at Methodist Hospital
-
Munster, Indiana, United States, 46321
- Community Hospital
-
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Iowa
-
Davenport, Iowa, United States, 52804
- Genesis Medical Center
-
Des Moines, Iowa, United States, 50309-1016
- CCOP - Iowa Oncology Research Association
-
Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
-
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Kansas
-
Wichita, Kansas, United States, 67214-3882
- CCOP - Wichita
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536-0093
- Markey Cancer Center at University of Kentucky Chandler Medical Center
-
Louisville, Kentucky, United States, 40207
- Consultants in Blood Disorders and Cancer
-
Louisville, Kentucky, United States, 40202-5070
- Norton Healthcare Cancer Center
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- CCOP - Ochsner
-
New Orleans, Louisiana, United States, 70112
- Tulane University Medical Center
-
New Orleans, Louisiana, United States, 70112
- Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans
-
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Maine
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Bangor, Maine, United States, 04401
- Eastern Maine Medical Center
-
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Maryland
-
Baltimore, Maryland, United States, 21237
- Franklin Square Hospital Center
-
Bethesda, Maryland, United States, 20889-5000
- National Naval Medical Center
-
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Massachusetts
-
Boston, Massachusetts, United States, 02118
- Cancer Research Center at Boston Medical Center
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Burlington, Massachusetts, United States, 01805
- Lahey Clinic Medical Center - Burlington
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Pittsfield, Massachusetts, United States, 01201
- Berkshire Medical Center
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Springfield, Massachusetts, United States, 01199
- Baystate Medical Center
-
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Michigan
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Ann Arbor, Michigan, United States, 48106
- CCOP - Michigan Cancer Research Consortium
-
Detroit, Michigan, United States, 48202
- Josephine Ford Cancer Center at Henry Ford Hospital
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East Lansing, Michigan, United States, 48824
- Michigan State University
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Grand Rapids, Michigan, United States, 49503
- CCOP - Grand Rapids
-
Kalamazoo, Michigan, United States, 49007-3731
- CCOP - Kalamazoo
-
Royal Oak, Michigan, United States, 48073-6769
- CCOP - Beaumont
-
Southfield, Michigan, United States, 48075-9975
- Providence Cancer Institute at Providence Hospital
-
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Minnesota
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Duluth, Minnesota, United States, 55805
- CCOP - Duluth
-
Minneapolis, Minnesota, United States, 55415
- Hennepin County Medical Center - Minneapolis
-
Saint Louis Park, Minnesota, United States, 55416
- CCOP - Metro-Minnesota
-
-
Missouri
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Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, United States, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, United States, 63141
- CCOP - St. Louis-Cape Girardeau
-
Saint Louis, Missouri, United States, 63110-0250
- St. Louis University Hospital Cancer Center
-
Springfield, Missouri, United States, 65807
- CCOP - Cancer Research for the Ozarks
-
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Montana
-
Billings, Montana, United States, 59101
- CCOP - Montana Cancer Consortium
-
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Nebraska
-
Omaha, Nebraska, United States, 68131
- CCOP - Missouri Valley Cancer Consortium
-
Omaha, Nebraska, United States, 68114
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
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New Jersey
-
Hackensack, New Jersey, United States, 07601
- CCOP - Northern New Jersey
-
New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
-
Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
-
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New Mexico
-
Albuquerque, New Mexico, United States, 87131
- MBCCOP - University of New Mexico HSC
-
-
New York
-
Albany, New York, United States, 12208
- New York Oncology Hematology, P.C. - Albany Regional Cancer Center
-
Bronx, New York, United States, 10451
- Lincoln Medical and Mental Health Center
-
Bronx, New York, United States, 10466
- MBCCOP-Our Lady of Mercy Cancer Center
-
Glens Falls, New York, United States, 12801
- Charles R. Wood Foundation Cancer Center at Glens Falls Hospital
-
Staten Island, New York, United States, 10305
- Staten Island University Hospital
-
Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
-
-
North Carolina
-
Burlington, North Carolina, United States, 27216
- Alamance Cancer Center
-
Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
Greenville, North Carolina, United States, 27858-4354
- Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
-
Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
North Dakota
-
Fargo, North Dakota, United States, 58122
- CCOP - Merit Care Hospital
-
-
Ohio
-
Akron, Ohio, United States, 44309
- Akron City Hospital
-
Canton, Ohio, United States, 44710
- Aultman Hospital Cancer Center at Aultman Health Foundation
-
Cincinnati, Ohio, United States, 45267-0502
- Charles M. Barrett Cancer Center at University Hospital
-
Cincinnati, Ohio, United States, 45236
- Jewish Hospital of Cincinnati, Incorporated
-
Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
-
Columbus, Ohio, United States, 43206
- CCOP - Columbus
-
Kettering, Ohio, United States, 45429
- CCOP - Dayton
-
Toledo, Ohio, United States, 43623-3456
- CCOP - Toledo Community Hospital
-
Warrensville Heights, Ohio, United States, 44122
- South Pointe Hospital - Cancer Care Center
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74136
- CCOP - Oklahoma
-
-
Oregon
-
Portland, Oregon, United States, 97213
- CCOP - Columbia River Oncology Program
-
-
Pennsylvania
-
Allentown, Pennsylvania, United States, 18103
- John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital
-
Danville, Pennsylvania, United States, 17822-2001
- Geisinger Medical Center
-
Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Cancer Center
-
Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
-
Pittsburgh, Pennsylvania, United States, 15212-4772
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, United States, 15213-3489
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
-
Reading, Pennsylvania, United States, 19612-6052
- Reading Hospital and Medical Center
-
Scranton, Pennsylvania, United States, 18501
- Mercy Hospital Cancer Center - Scranton
-
Wynnewood, Pennsylvania, United States, 19096
- CCOP - MainLine Health
-
York, Pennsylvania, United States, 17315
- Wellspan Health - York Cancer Center
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- CCOP - Greenville
-
Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37916
- Thompson Cancer Survival Center
-
Memphis, Tennessee, United States, 38146
- Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis
-
-
Texas
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
-
Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
Lubbock, Texas, United States, 79410-1894
- Joe Arrington Cancer Research and Treatment Center
-
San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
-
Temple, Texas, United States, 76508
- CCOP - Scott and White Hospital
-
-
Utah
-
Provo, Utah, United States, 84604
- Utah Valley Regional Medical Center - Provo
-
-
Vermont
-
Bennington, Vermont, United States, 05201
- Green Mountain Oncology Group
-
-
Virginia
-
Newport News, Virginia, United States, 23606
- Virginia Oncology Associates - Newport News
-
Norfolk, Virginia, United States, 23507
- Eastern Virginia Medical School
-
Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
-
Roanoke, Virginia, United States, 24014
- Oncology and Hematology Associates of Southwest Virginia, Inc.
-
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Washington
-
Seattle, Washington, United States, 98101
- CCOP - Virginia Mason Research Center
-
Seattle, Washington, United States, 98109
- Puget Sound Oncology Consortium
-
Tacoma, Washington, United States, 98405-0986
- CCOP - Northwest
-
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West Virginia
-
Charleston, West Virginia, United States, 25304-1297
- Charleston Area Medical Center
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Parkersburg, West Virginia, United States, 26102
- Camden-Clark Memorial Hospital
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
-
Marshfield, Wisconsin, United States, 54449
- CCOP - Marshfield Clinic Research Foundation
-
Milwaukee, Wisconsin, United States, 53215
- St. Luke's Medical Center
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
DISEASE CHARACTERISTICS:
Histologically confirmed invasive adenocarcinoma of the breast
Confined to the breast and ipsilateral axilla on clinical exam
- Stage I, II, or IIIA (cT1-3, N0-1, M0)
At least one axillary lymph node with evidence of tumor on histologic exam
- Sentinel node biopsy allowed if followed by axillary dissection
- No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor
- No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign
- Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR
Prior lumpectomy and axillary dissection
- Patients must receive radiotherapy after randomization (not before) AND after chemotherapy
- Margins must be clear
- No ipsilateral lymph nodes that are fixed to one another or to other structures (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are considered axillary nodes)
- No histologically evident invasive tumor or ductal carcinoma in situ
- No diffuse tumors by mammography that would not be surgically amenable to lumpectomy
No other dominant mass in the ipsilateral breast remnant unless one of the following is true:
- Histologically benign
- Surgically removed with clear margins if malignant
No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude
- Tethering or dimpling of the skin or nipple inversion allowed
No metastatic disease
- Skeletal pain allowed if bone scan negative for metastases
Hormone receptor status:
- Estrogen and progesterone status determined
PATIENT CHARACTERISTICS:
Age:
- greater than or equal to 18 years
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- At least 10 years, excluding diagnosis of cancer
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3 (may be less, if in the opinion of the investigator, this represents an ethnic or racial variation)
- Platelet count at least 100,000/mm^3* NOTE: *If platelet count is above the upper limit of normal (ULN), significant underlying hematologic disorders must be excluded
Hepatic:
- Bilirubin no greater than ULN
- Alkaline phosphatase less than 2.5 times ULN*
- SGOT less than 1.5 times ULN*
- No nonmalignant systemic hepatic disease that would preclude study participation NOTE: *Alkaline phosphatase and SGOT cannot both be greater than ULN
Renal:
- Creatinine no greater than normal
- No nonmalignant systemic renal disease that would preclude study participation
Cardiovascular:
- No nonmalignant systemic cardiovascular disease that would preclude study participation
- LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram
No active cardiac disease that would preclude use of doxorubicin or docetaxel, including the following:
- Any prior myocardial infarction
- Angina pectoris requiring anti-anginal medication
- History of congestive heart failure
- Cardiac arrhythmia requiring medication
- Severe conduction abnormality
- Valvular disease with documented cardiac function compromise
- Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at least LLN
- Poorly controlled hypertension (diastolic greater than 100 mm/Hg)
- Hypertension well controlled by medication allowed
Other:
- No grade 2 or greater peripheral neuropathy
No other prior malignancy within the past 5 years except:
- Effectively treated squamous cell or basal cell skin cancer
- Surgically treated carcinoma in situ of the cervix
- Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No nonmalignant systemic disease that would preclude study participation
- No diabetes with morning fasting blood glucose of 200 mg/dL or greater
- No psychiatric or addictive disorders that would preclude informed consent
- No contraindication to corticosteroids that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy for breast cancer
Chemotherapy:
- No prior chemotherapy for breast cancer
- No prior anthracyclines or taxanes
- No other concurrent investigational chemotherapy
Endocrine therapy:
- No prior hormonal therapy for breast cancer
- No concurrent hormonal birth control methods or other hormonal therapy
- No concurrent raloxifene, including for osteoporosis
- Concurrent low-dose topical estrogen in the form of conjugated estrogen ring or conjugated estrogen vaginal cream (dose no more than 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week) allowed
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for this malignancy
Surgery:
- See Disease Characteristics
- No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy margins)
Other:
- No prior systemic therapy for this malignancy
- No concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium-channel blockers) for cardiac arrhythmia, angina, or congestive heart failure (allowed if administered for other reasons [e.g., hypertension])
- Concurrent bisphosphonates allowed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: Doxorubicin + Cyclophosphamide, then Docetaxel
Doxorubicin + Cyclophosphamide, then Docetaxel
|
Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles
Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
Other Names:
Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
Other Names:
|
Experimental: Arm 2: Doxorubicin + Docetaxel
Doxorubicin + Docetaxel
|
Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
Other Names:
Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
Other Names:
|
Experimental: Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Doxorubicin + Docetaxel + Cyclophosphamide
|
Arm 1: 600 mg/m2 IV every 21 days for 4 cycles; Arm 3: 500 mg/m2 IV every 21 days for 4 cycles
Arm 1: 100 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 75 mg/m2 IV every 21 days for 4 cycles
Other Names:
Arm 1: 60 mg/m2 IV every 21 days for 4 cycles; Arms 2 and 3: 50 mg/m2 IV every 21 days for 4 cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 8 years
|
8 years
|
Disease Free Survival
Time Frame: time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event
|
time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicities Among the 3 Regimens
Time Frame: 9 years
|
9 years
|
Quality of Life Among Breast Cancer Patients
Time Frame: baseline, 9 weeks, and 6, 12, 18, and 24 months
|
baseline, 9 weeks, and 6, 12, 18, and 24 months
|
Amenorrhea in Premenopausal Women
Time Frame: baseline, 9 weeks, and 6, 12, 18, and 24 months
|
baseline, 9 weeks, and 6, 12, 18, and 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Norman Wolmark, MD, NSABP Foundation Inc
Publications and helpful links
General Publications
- Swain SM, Land SR, Ritter MW, Costantino JP, Cecchini RS, Mamounas EP, Wolmark N, Ganz PA. Amenorrhea in premenopausal women on the doxorubicin-and-cyclophosphamide-followed-by-docetaxel arm of NSABP B-30 trial. Breast Cancer Res Treat. 2009 Jan;113(2):315-20. doi: 10.1007/s10549-008-9937-0. Epub 2008 Feb 27.
- Ganz PA, Land SR, Geyer CE, et al.: NSABP B-30: definitive analysis of quality of life (QOL) and menstrual history (MH) outcomes from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-76, 2008.
- Swain SM, Jeong JH, Geyer CE, et al.: NSABP B-30: definitive analysis of patient outcome from a randomized trial evaluating different schedules and combinations of adjuvant therapy containing doxorubicin, docetaxel and cyclophosphamide in women with operable, node-positive breast cancer. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-75, 2008.
- Swain SM, Land SR, Sundry R, et al.: Amenorrhea in premenopausal women on the doxorubicin (A) and cyclophosphamide (C) followed-by docetaxel (T) arm of NSABP B-30: preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-537, 13s, 2005.
- Bandos H, Melnikow J, Rivera DR, Swain SM, Sturtz K, Fehrenbacher L, Wade JL 3rd, Brufsky AM, Julian TB, Margolese RG, McCarron EC, Ganz PA. Long-term Peripheral Neuropathy in Breast Cancer Patients Treated With Adjuvant Chemotherapy: NRG Oncology/NSABP B-30. J Natl Cancer Inst. 2018 Feb 1;110(2):djx162. doi: 10.1093/jnci/djx162.
- Swain SM, Jeong JH, Geyer CE Jr, Costantino JP, Pajon ER, Fehrenbacher L, Atkins JN, Polikoff J, Vogel VG, Erban JK, Rastogi P, Livingston RB, Perez EA, Mamounas EP, Land SR, Ganz PA, Wolmark N. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N Engl J Med. 2010 Jun 3;362(22):2053-65. doi: 10.1056/NEJMoa0909638.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Cyclophosphamide
- Doxorubicin
Other Study ID Numbers
- NSABP B-30
- CDR0000066914
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