Overview

This trial has been completed.

Condition breast cancer
Treatments m, x
Phase phase 3
Sponsor National Cancer Institute (NCI)
Start date September 1979
End date November 2016
Trial size 256 participants
Trial identifier NCT01468883, 79-C-0111, 790111, NCT00026845

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Excisional biopsy plus radiation
x
Excisional biopsy plus radiation
(Active Comparator)
Modified radical mastectomy
m
Modified radical mastectomy

Primary Outcomes

Measure
To compare the results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy
time frame: Survival Rate

Eligibility Criteria

Female participants from 18 years up to 99 years old.

- 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.

Additional Information

Official 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
Principal investigator Kevin A Camphausen, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC).