Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy
- 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
- 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
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Potential acute, late skin, and subcutaneous toxicity
Richard C. Zellars, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|