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