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

NCT01468883 | Completed Phase 3

• 2 other identifiers: 79011179-C-0111
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Surgery; Radiation

Outcome Measures

Primary Outcomes (1)

• Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy

  To compare the results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy

  survival rate completion of study

Study Arms (2)

M

ACTIVE COMPARATOR

Modified radical mastectomy

Procedure: M

X

EXPERIMENTAL

Excisional biopsy plus radiation

Radiation: X

Interventions

M PROCEDURE

Modified radical mastectomy

M

X RADIATION

Excisional biopsy plus radiation

X

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kevin A Camphausen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2011
• First Posted: November 10, 2011
• Study Start: September 4, 1979
• Primary Completion: September 27, 2016
• Study Completion: November 17, 2016
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

US (1)