Status:
COMPLETED
The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 biops...
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 biops...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 4 1979
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2016
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01468883
Start Date
September 4 1979
End Date
November 17 2016
Last Update
April 26 2024
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892