A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients With Axillary Node-Positive Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the
breast with histologically involved lymph nodes (T1, 2, or 3; N1 or 2; M0) OR
high-risk node-negative disease (T2 or 3; N0)

- Primary tumor at least 2.1 cm in diameter for node-negative disease

- Bilateral breast disease allowed if at least 1 primary tumor meets the criteria
above

- Must have had at least 6 axillary lymph nodes removed at dissection and at least one
node positive for metastasis OR

- Sentinel node biopsy negative for metastasis (sentinel node biopsy positive allowed
if enrolled on American College of Surgery Trial Z0011 and have beenrandomized to
receive no axillary dissection)

- Additional axillary nodes may be obtained provided they are also negative for
metastasis

- Complete tumor removal by either a modified radical mastectomy or local excision plus
axillary lymph node dissection (i.e., breast conservation therapy) or sentinel node
biopsy

- Tumor-free margins at least 1 mm for both invasive and noninvasive carcinoma
except for lobular carcinoma in situ (less than 1 mm allowed)

- Concurrent enrollment on American College of Surgery Trial Z0010, Z0011, or NSABP
B-32 allowed

- Hormone receptor status:

- Estrogen receptor status positive, negative, or unknown

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Neutrophil count at least 1,500/mm^3

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

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 2 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- No history of myocardial infarction

- No congestive heart failure

- No significant ischemic or valvular heart disease

Other:

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

- No hypersensitivity to paclitaxel or docetaxel or other similarly formulated drugs
(with Cremophor or polysorbate)

- Not pregnant or nursing

- Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for breast cancer

Endocrine therapy:

- Prior tamoxifen of no more than 4 weeks duration for breast cancer allowed

- Prior tamoxifen or other selective estrogen receptor modulator (SERM) for
chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications
(e.g., osteoporosis) allowed

- No concurrent tamoxifen or other SERMs

Radiotherapy:

- No prior radiotherapy for this malignancy

- At least 2 weeks since prior radiotherapy to the breast for ductal carcinoma in situ

Surgery:

- See Disease Characteristics

- Less than 84 days since prior surgical procedure to adequately treat primary tumor