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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:
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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
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Axillary Dissection
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Radioactive Implantation
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Breast Irradiation
- Recruitment Keyword(s):
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None
- Condition(s):
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Breast Cancer
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Interventions:
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Procedure/Surgery: Total mastectomy, axillary dissection
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Procedure/Surgery: Excisional biopsy, axillary dissection
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Procedure/Surgery: Radiotherapy
- Supporting Site:
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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
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009
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