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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

79-C-0111

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Female
Min Age: 18
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Male;
Children

Keywords

Breast Cancer;
Surgery;
Radiation

Recruitment Keyword(s)

None

Condition(s)

Breast Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Procedure/Surgery: M
Radiation: X

Supporting Site

National Cancer Institute

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.

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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kevin A. Camphausen, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM B2-3675
10 CENTER DR
BETHESDA MD 20892
(240) 760-6205
camphauk@mail.nih.gov

Theresa Cooley Zgela, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room B2-5530
10 Center Drive
Bethesda, Maryland 20892
(301) 451-8905
tcooley@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT01468883

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