Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III Randomized Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed invasive carcinoma of the breast with 0-3 positive axillary
lymph nodes

- Meets 1 of the following criteria for node-negative disease:

- Negative sentinel lymph node biopsy

- At least 6 negative axillary lymph nodes removed and determined to be
negative by axillary dissection

- Meets 1 of the following criteria for node-positive disease (1-3 positive
axillary lymph nodes):

- At least 1 positive lymph node by sentinel lymph node biopsy AND at least 6
axillary lymph nodes removed by axillary dissection; of all the nodes
removed from both the sentinel lymph node biopsy and the axillary
dissection, 1-3 must be positive

- At least 6 lymph nodes removed by axillary dissection; 1-3 nodes from the
axillary dissection must be positive

- "High-risk" disease that warrants chemotherapy (ultimately determined by the treating
physician)

- Modified radical mastectomy or lumpectomy within the past 84 days required

- Negative tumor margins for invasive cancer and ductal carcinoma in situ (DCIS)

- Lobular carcinoma in situ (LCIS) at the margin allowed

- Multicentric disease allowed provided margins and axillary nodes are negative after
resection

- Bilateral synchronous disease allowed

- Invasive cancer on one side and DCIS or LCIS on the contralateral side is allowed
provided all other eligibility criteria are met

- No locally advanced, inflammatory, or metastatic breast cancer

- No dermal lymphatics involvement, even if there are no clinical signs of inflammatory
cancer

- HER2/neu positive, negative, or unknown

- Hormone receptor status:

- Any estrogen and/or progesterone receptor status

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Premenopausal or postmenopausal

Performance status:

- CTC 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No active congestive heart failure

- No myocardial infarction within the past 6 months

Other:

- Not pregnant or nursing

- Fertile patients must use effective nonhormonal contraception during and for at least
2 months after study participation

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior trastuzumab (Herceptin^®) for this malignancy

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy for this malignancy

- No other concurrent chemotherapy

Endocrine therapy:

- No prior hormonal therapy for this malignancy except tamoxifen given for up to 4
weeks

- Prior tamoxifen or other selective estrogen receptor modulators (SERMs) for
prevention or other indications (e.g., osteoporosis) allowed

- No concurrent exogenous hormonal therapy (including oral contraceptives,
postmenopausal hormone replacement therapy, or raloxifene) except:

- Steroids for adrenal failure

- Hormonal agents for nondisease-related conditions (e.g., insulin for diabetes or
synthroid for hypothyroidism)

- Intermittent dexamethasone as an antiemetic and premedication for paclitaxel

- No concurrent tamoxifen or other SERMs

Surgery:

- See Disease Characteristics

Other:

- No concurrent dexrazoxane

- No concurrent raloxifene

- Concurrent bisphosphonates for osteoporosis allowed

- Concurrent trastuzumab (Herceptin^®) allowed for patients with HER2-positive disease

- Concurrent enrollment on adjuvant bisphosphonate studies allowed

- Concurrent enrollment on adjuvant hormonal studies allowed provided hormonal therapy
does not commence until completion of study chemotherapy