The Treatment of Stage I and II Breast Cancer With Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Radiotherapy

Patients with biopsy proven breast cancer, clinical stage I and II, will be randomized to
receive treatment by one of two methods: (1) total mastectomy and axillary dissection; or (2)
excisional biopsy, axillary dissection, and definitive irradiation.

Data from single institutions and from retrospective comparisons suggest that definitive
irradiation with cosmetically acceptable breast preservation offers survival and local
control results equivalent to extirpative surgery. This study will test this hypothesis in a
prospective, randomized manner. After primary therapy, subjects will be followed for: (1)
survival; (2) sites of recurrence; (3) anatomic function; (4) complications of therapy; and
(5) cosmesis.

- INCLUSION CRITERIA:

Female patients of any age with a dominant breast mass meeting the following requirements
are eligible for this protocol:

On clinical evaluation the tumor must be confined to the breast and axillary lymph nodes
(stage I and II).

Biopsy of the tumor must be classified as a primary breast neoplasm of epithelial origin.

Patients must be geographically accessible for follow-up and willing to return for the
follow-up at the NCI.

Patient must be mentally competent to understand and give informed consent for the
protocol.

EXCLUSION CRITERIA:

Patients will be excluded from this protocol for the following reasons:

Advanced local disease or distant metastases (stage III and IV);

Inflammatory cancer;

Chronic diseases such as heart, lung, liver, kidney, blood, or metabolic disorders which
may render the patient a poor operative risk;

History of another cancer other than skin cancer (non-melanoma);

Concurrent pregnancy or lactation;

Non-palpable lesions manifested only by nipple discharge or skin rash (Paget's disease);

Previous therapy to the breast cancer other than excisional biopsy;

Multiple masses or multiple suspicious areas on mammogram unless all but one are proven
histologically benign; and

Bilateral breast carcinoma, either invasive or in-situ.