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The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT01468883•National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Detailed Description

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Key Dates

Start Date

September 4, 1979

Primary Completion Date

September 27, 2016

Completion Date

November 17, 2016

Last Updated

April 26, 2024

Enrollment

256

ACTUAL participants

Conditions

Breast Cancer

Interventions

PROCEDURE

RADIATION

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Breast CancerHigh Risk of Breast Cancer

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RECRUITINGPHASE1

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Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Treatment of Stage I and II Carcinoma of the Breast With Mastectomy and Axillary Dissection Versus Excisional Biopsy, Axillary Dissection, and Definitive Irradiation

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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