Study on Chemotherapy Combinations for Treating Breast Cancer After Surgery

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