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

• Determine the feasibility of concurrent paclitaxel and breast radiotherapy [ Time Frame: Followed every 3 months for 1 year ] [ Designated as safety issue: Yes ]
  Ability to deliver appropriate doses of radiation therapy within the appropriate time course and calculate the chemotherapy dose achieved during concurrent Taxol and radiation therapy.
  
  

• Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  These parameters will be assessed by medical and radiation oncology. We expect at least a > 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated.
  
  
• Pulmonary function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  Combined treatment impact on pulmonary function. Evidence of pulmonary toxicity demonstrated by a reduction in DLCO (Diffusing Capacity of the Lung for Carbon Monoxide).
  
  
• Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Patients followed for long term survival.
  
  

Drug: paclitaxel
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.
Procedure: adjuvant therapy
doxorubicin and cyclophosphamide adjuvant regimen
Radiation: radiation therapy
Patients also undergo concurrent radiotherapy 5 days a week for approximately 6-7 weeks.

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.