Partial Breast Irradiation With Chemotherapy

OBJECTIVES:

• Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation (PBI) and concurrent cyclophosphamide/doxorubicin (AC) chemotherapy.
• Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these patients.
• Assess the local control rate in patients treated with this regimen.

OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for approximately 10 years.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast by routine hematoxylin and eosin (H&E) staining

• Primary tumor ≤ 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2, pathologic N0-N1, M0)

• Patients with lymph nodes positive only by cytokeratin staining (i.e., H&E negative) are eligible
• No squamous cell carcinoma or sarcoma of the breast
• Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy within the past 14 weeks

• Surgical margins at the time of SM must be negative (> 3 mm) for both invasive carcinoma and for non-invasive ductal carcinoma
• No active local-regional disease
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Sex: female
• Menopausal status not specified
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective non-hormonal contraception
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other serious or poorly controlled medical or psychiatric condition that could be exacerbated by, or complicate compliance with study treatment

PRIOR CONCURRENT THERAPY:

• No prior radiation therapy to the breast
• No prior trastuzumab (Herceptin ®)
• No other concurrent chemotherapy
• No concurrent hormonal therapy except the following:

• Steroids given for adrenal failure
• Hormones administered for non-disease-related conditions (e.g., insulin for diabetes, synthroid for hypothyroidism)
• Intermittent dexamethasone as an antiemetic or premedication