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

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT01468883
• Collaborator: (none)
• Enrollment: 256
• Location: 1
• Arms: 2
• Actual Duration (Months): 446.5
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Procedure: M; Radiation: X	Phase 3

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 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 4, 1979
• Actual Primary Completion Date: Sep 27, 2016
• Actual Study Completion Date: Nov 17, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: M Modified radical mastectomy	Procedure: M; Modified radical mastectomy
Experimental: X Excisional biopsy plus radiation	Radiation: X; Excisional biopsy plus radiation

Outcome Measures

Primary Outcome Measures

1. Results of excisional biopsy followed by radiation therapy versus modified radiacal mastectomy [survival rate completion of study]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Kevin A Camphausen, M.D., National Cancer Institute (NCI)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NIH Clinical Center Detailed Web Page

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT01468883
• Other Study ID Numbers: 790111; 79-C-0111; NCT00026845
• First Posted: Nov 10, 2011
• Last Update Posted: Apr 8, 2022
• Last Verified: Aug 6, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Cancer Institute (NCI): Breast Cancer; Surgery; Radiation
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Apr 8, 2022