Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women With One to Three Positive Axillary Nodes Phase III
- Compare overall and disease-free survival in women with stage II breast cancer with one
to three positive nodes treated with radiotherapy vs observation only after mastectomy
and adjuvant chemotherapy and/or hormonal therapy.
- Compare local regional control in patients treated with these regimens.
- Assess the potential toxic effects of radiotherapy in this patient population.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
systemic hormonal therapy (chemotherapy with or without hormonal therapy vs hormonal therapy
alone), prior taxane exposure (yes vs no), and duration of chemotherapy (no chemotherapy vs
less than 3 months vs 3-5 months vs 6 months or more). Patients are randomized to one of two
- Arm I: Patients undergo radiotherapy 5 days a week for 5 weeks.
- Arm II: Patients are observed for disease progression. Patients are followed every 6
months for 2 years and then annually for 15 years.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per treatment arm) will be accrued for
this study within 5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Lori J. Pierce, MD
University of Michigan Cancer Center
United States: Federal Government