Trial Information

The Treatment Of Clinical Stage I And II Carcinoma Of The Breast With Mastectomy And Axillary Dissection Versus Excisional Biopsy, Axillary Dissection And Definitive Irradiation

OBJECTIVES:

- Compare the overall and disease-free survival of women with stage I or II breast cancer
treated with mastectomy and axillary dissection vs excisional biopsy, axillary
dissection, and definitive radiotherapy.

- Compare in-breast only failure in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo total mastectomy and axillary dissection.

- Arm II: Patients undergo excisional biopsy and axillary dissection followed by whole
breast radiotherapy and a boost to the tumor bed. Patients with positive axillary
dissections undergo radiotherapy to the supraclavicular nodes.

In both arms, patients with positive nodes receive cyclophosphamide and doxorubicin.

Patients are followed for at least 20 years.

PROJECTED ACCRUAL: A total of 237 patients (116 for arm I and 121 for arm II) were accrued
for this study within 8 years.