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.

Condition	Treatment or Intervention	Phase
Breast Cancer	Procedure: Total mastectomy, axillary dissection  Procedure: Excisional biopsy, axillary dissection  Procedure: Radiotherapy	Phase II

Further Study Details: 

Expected Total Enrollment:  520

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.

Genders Eligible for Study:  Female

Criteria

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.

Maryland
      National Cancer Institute (NCI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

Study ID Numbers:  790111; 79-C-0111
Record last reviewed:  June 1, 2004
Last Updated:  November 23, 2004
Record first received:  November 14, 2001
ClinicalTrials.gov Identifier:  NCT00026845
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08