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. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.
PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
DISEASE CHARACTERISTICS:
* Histologically confirmed stage I-III invasive breast cancer
* Operable disease
* Stage I, II, IIIA, and IIIC (T1-3, N3a only)
* No T4 tumors
* High-risk disease, defined by 1 of the following:
* Tumor ≥ 2 cm in greatest diameter (includes both invasive and intraductal component)
* Patients with nodal status of N0+ (i.e., no cluster of tumor cells in any node greater than 0.2 mm) are considered to be node negative and must have a primary tumor ≥ 2 cm in size or have a tumor ≥ 1 cm with high risk features
* Patients who are node negative on the basis of a sentinel node procedure and fewer than 6 axillary nodes are removed are eligible OR at least 6 axillary or intramammary nodes must be negative
* Tumor ≥ 1 cm in diameter and meeting 1 of the following criteria:
* ER-negative and PgR-negative
* ER-positive or PgR-positive with a Genomic Health Recurrence Score of ≥ 26
* One or more axillary or intramammary nodes are involved by metastatic breast cancer
* If one or more nodes is involved, a minimum of 6 axillary or intramammary nodes must have been examined histologically
* Patients with N0(I+) disease will be considered node negative
* HER2/neu-positive tumors (3+ by immunohistochemical staining or amplified by fluorescence in-situ hybridization) allowed
* Bilateral synchronous breast cancer diagnosed within 1 month of each other allowed provided the higher TNM stage primary tumor meets the eligibility criteria
* Prior modified radical mastectomy OR local excision of all tumors with axillary lymph node dissection or sentinel node resection required
* No more than 84 days since prior surgery for the primary tumor and/or axilla
* Final resection margins for the primary tumor must be histologically negative for invasive cancer and ductal carcinoma in situ
* Resection margins positive for lobular carcinoma in situ are allowed
* Hormone receptor status:
* Estrogen receptor status known
* Progesterone receptor status known
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Male or female
Menopausal status
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2 times ULN
* SGOT or SGPT no greater than 2 times ULN
Renal
* Creatinine no greater than ULN
Cardiovascular
* No congestive heart failure
* No active angina pectoris
* LVEF greater than or equal to the lower limit of normal\* by MUGA or echocardiogram NOTE: Patients age 60 and over OR with a history of hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical carcinoma, or lobular carcinoma in situ of the breast
* Prior invasive breast cancer or ductal carcinoma in situ allowed if disease-free for 5 years
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior cytotoxic chemotherapy for this breast cancer
* No prior chemotherapy with an anthracycline, anthracenedione, or taxane
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for this malignancy
* At least 2 weeks since prior radiotherapy for ductal carcinoma in situ
Surgery
* See Disease Characteristics
Primary outcome measure(s)
Disease-free Survival — every 6 months (annually for mammograms) for 5 years Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Overall Survival — Every 6 months for 5 years Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Trial sites (542)
Facility
City
Region
Status
Regional Medical Center
Anniston
Alabama
UAB Comprehensive Cancer Center
Birmingham
Alabama
Providence Cancer Center at Providence Hospital
Mobile
Alabama
Providence Cancer Center
Anchorage
Alaska
Mayo Clinic Scottsdale
Scottsdale
Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson
Arizona
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith
Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock
Arkansas
Alta Bates Summit Comprehensive Cancer Center
Berkeley
California
Peninsula Medical Center
Burlingame
California
East Bay Radiation Oncology Center
Castro Valley
California
Valley Medical Oncology Consultants - Castro Valley
Castro Valley
California
Valley Medical Oncology
Fremont
California
California Cancer Center - Woodward Park Office
Fresno
California
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach
California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles
California
Contra Costa Regional Medical Center
Martinez
California
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville
California
Memorial Medical Center
Modesto
California
El Camino Hospital Cancer Center
Mountain View
California
Sutter Health - Western Division Cancer Research Group
Novato
California
Highland General Hospital
Oakland
California
Alta Bates Summit Medical Center - Summit Campus
Oakland
California
Bay Area Breast Surgeons, Incorporated
Oakland
California
CCOP - Bay Area Tumor Institute
Oakland
California
Larry G Strieff MD Medical Corporation
Oakland
California
Tom K Lee, Incorporated
Oakland
California
St. Joseph Hospital Regional Cancer Center - Orange
Orange
California
Desert Regional Medical Center Comprehensive Cancer Center
Palm Springs
California
Valley Medical Oncology Consultants - Pleasanton
Pleasanton
California
Sutter Cancer Center at Roseville Medical Center
Roseville
California
Sutter Cancer Center
Sacramento
California
University of California Davis Cancer Center
Sacramento
California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco
California
California Pacific Medical Center - California Campus
San Francisco
California
Doctors Medical Center - San Pablo Campus
San Pablo
California
Sutter Solano Medical Center
Vallejo
California
San Luis Valley Regional Medical Center
Alamosa
Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora
Colorado
Memorial Hospital Cancer Center - Colorado Springs
Colorado Springs
Colorado
+ 502 more sites — see the full list on the official registry below.
More SWOG Cancer Research Network trials in Israel
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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