Protocol Number: 79-C-0111

Title:

The Treatment of Stage I and II Carcinoma of the Breast with Mastectomy and Axillary Dissection vs. Excisional Biopsy, Axillary Dissection, and Definitive Irradiation

Number:

79-C-0111

Summary:

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Female

Referral Letter Required: No

Population Exclusion(s): Male

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Total Mastectomy

Axillary Dissection

Radioactive Implantation

Breast Irradiation

Recruitment Keyword(s):

None

Condition(s):

Breast Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Procedure/Surgery: Total mastectomy, axillary dissection

Procedure/Surgery: Excisional biopsy, axillary dissection

Procedure/Surgery: Radiotherapy

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s): Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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