Breast Cancer Clinical Trial

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

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

5351

Study ID:

NCT00003782

Recruitment Status:

Completed

Sponsor:

NSABP Foundation Inc

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There are 154 Locations for this study

See Locations Near You

Comprehensive Cancer Institute
Huntsville Alabama, 35801, United States
Providence Alaska Medical Center
Anchorage Alaska, 99519, United States
CCOP - Western Regional, Arizona
Phoenix Arizona, 85006, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
California Cancer Center
Fresno California, 93720, 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
Rebecca and John Moores UCSD Cancer Center
La Jolla California, 92093, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda California, 92354, United States
Pacific Shores Medical Group
Long Beach California, 90813, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange California, 92868, United States
Comprehensive Cancer Centers of the Desert
Palm Springs California, 92262, United States
Stanford Cancer Center at Stanford University Medical Center
Palo Alto California, 94305, 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
Catholic Healthcare West - Westbay Region
San Francisco California, 94107, 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, United States
University of Connecticut Cancer Center at University of Connecticut Health Center
Farmington Connecticut, 06360, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
CCOP - Christiana Care Health Services
Wilmington Delaware, 19899, United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia, 20060, United States
Morton Plant Hospital
Clearwater Florida, 33756, United States
Halifax Medical Center
Daytona Beach Florida, 32114, United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville Florida, 32207, United States
CCOP - Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Miami Sylvester Cancer Center
Miami Florida, 33136, United States
MD Anderson Cancer Center Orlando
Orlando Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
Medical College of Georgia Comprehensive Cancer Center
Augusta Georgia, 30912, United States
Dwight David Eisenhower Army Medical Center
Fort Gordon Georgia, 30905, 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, United States
Rush-Presbyterian-St. Luke's 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
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, United States
St. Vincent Hospital and Health Care Center
Indianapolis Indiana, 46260, United States
Community Hospital
Munster Indiana, 46321, United States
Genesis Medical Center
Davenport Iowa, 52804, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
Norton Healthcare Cancer Center
Louisville Kentucky, 40202, 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 University Medical Center
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor Maine, 04401, United States
Franklin Square Hospital Center
Baltimore Maryland, 21237, United States
National Naval Medical Center
Bethesda Maryland, 20889, United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts, 02118, United States
Lahey Clinic Medical Center - Burlington
Burlington Massachusetts, 01805, United States
Berkshire Medical Center
Pittsfield Massachusetts, 01201, United States
Baystate Medical Center
Springfield Massachusetts, 01199, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Josephine Ford Cancer Center at Henry Ford Hospital
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, United States
CCOP - Beaumont
Royal Oak Michigan, 48073, United States
Providence Cancer Institute at Providence Hospital
Southfield Michigan, 48075, 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
St. Louis University Hospital Cancer Center
Saint Louis Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, 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
New Brunswick New Jersey, 08903, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
New York Oncology Hematology, P.C. - Albany Regional Cancer Center
Albany New York, 12208, United States
Lincoln Medical and Mental Health Center
Bronx New York, 10451, United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx New York, 10466, United States
Charles R. Wood Foundation Cancer Center at Glens Falls Hospital
Glens Falls New York, 12801, United States
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
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, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville North Carolina, 27858, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem North Carolina, 27157, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Akron City Hospital
Akron Ohio, 44309, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton Ohio, 44710, United States
Jewish Hospital of Cincinnati, Incorporated
Cincinnati Ohio, 45236, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus Ohio, 43210, United States
CCOP - Dayton
Kettering Ohio, 45429, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43623, United States
South Pointe Hospital - Cancer Care Center
Warrensville Heights Ohio, 44122, 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, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia Pennsylvania, 19107, United States
Albert Einstein Cancer Center
Philadelphia Pennsylvania, 19141, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15213, United States
Reading Hospital and Medical Center
Reading Pennsylvania, 19612, United States
Mercy Hospital Cancer Center - Scranton
Scranton Pennsylvania, 18501, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
Wellspan Health - York Cancer Center
York Pennsylvania, 17315, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Thompson Cancer Survival Center
Knoxville Tennessee, 37916, United States
Baptist Cancer Institute - Memphis at Baptist Memorial Hospital - Memphis
Memphis Tennessee, 38146, United States
Medical City Dallas Hospital
Dallas Texas, 75230, United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75235, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Green Mountain Oncology Group
Bennington Vermont, 05201, United States
Virginia Oncology Associates - Newport News
Newport News Virginia, 23606, United States
Eastern Virginia Medical School
Norfolk Virginia, 23507, United States
MBCCOP - Massey Cancer Center
Richmond Virginia, 23298, United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke Virginia, 24014, 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, United States
Charleston Area Medical Center
Charleston West Virginia, 25304, United States
Camden-Clark Memorial Hospital
Parkersburg West Virginia, 26102, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54301, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield Wisconsin, 54449, United States
St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Tom Baker Cancer Center - Calgary
Calgary Alberta, T2N 4, Canada
CancerCare Manitoba
Winnipeg Manitoba, R3E 0, Canada
Credit Valley Hospital
Mississauga Ontario, L5M 2, Canada
Ottawa Regional Cancer Centre
Ottawa Ontario, K1H 1, Canada
St. Michael's Hospital - Toronto
Toronto Ontario, M5B 1, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2L-4, Canada
Royal Victoria Hospital - Montreal
Montreal Quebec, H3A 1, Canada
Montreal General Hospital
Montreal Quebec, H3G 1, Canada
Jewish General Hospital - Montreal
Montreal Quebec, H3T 1, Canada
St. Mary's Hospital Center
Montreal Quebec, H3T 1, Canada
Hopital du Saint-Sacrement, Quebec
Quebec City Quebec, G1S 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

5351

Study ID:

NCT00003782

Recruitment Status:

Completed

Sponsor:


NSABP Foundation Inc

How clear is this clinincal trial information?

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