The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation
The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection vs. Excisional Biopsy Axillary Dissection, and Definitive Irradiation
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: M
Modified radical mastectomy
|
Modified radical mastectomy
|
|
Experimental: X
Excisional biopsy plus radiation
|
Excisional biopsy plus radiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
Time Frame: survival rate completion of study
|
To compare the results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
|
survival rate completion of study
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kevin A Camphausen, M.D., National Cancer Institute (NCI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 790111
- 79-C-0111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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