Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer

OBJECTIVES:

• Determine the feasibility of concurrent paclitaxel and breast radiotherapy in women with stage II or III breast cancer who have had primary breast conserving surgery and adjuvant chemotherapy.
• Assess the cosmetic results of breast conservation after this treatment in these patients.
• Determine the pulmonary toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours every 21 days for 4 courses beginning 3 weeks after completion of the last doxorubicin and cyclophosphamide adjuvant regimen. Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 3 months for 1 year, every 6 months for the next 5 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 12-18 months.

DISEASE CHARACTERISTICS:

• Stage II or III invasive breast cancer
• Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required
• No prior contralateral breast cancer
• No metastatic disease
• Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy
• Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks
• Candidate for definitive radiotherapy
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm3
• Granulocyte count at least 2,000/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT/AST no greater than 1.5 times ULN

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No concurrent poorly controlled ischemic heart disease or congestive heart failure
• LVEF at least 45% by MUGA scan or echocardiogram

Pulmonary:

• No concurrent severe chronic obstructive or restrictive pulmonary disease

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No concurrent severe medical or psychiatric illness
• No concurrent severe diabetes mellitus
• No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent filgrastim (G-CSF)

Chemotherapy:

• See Disease Characteristics
• Prior tamoxifen allowed
• No concurrent tamoxifen

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiation to the breast

Surgery:

• Recovered form prior surgery

Other:

• No concurrent adjuvant therapy on another clinical trial