NCT01468883

CompletedPhase 3

The Treatment of Stage I and II Carcinoma of the Breast With...

National Cancer Institute (NCI)Source

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Other study identifiers

Sponsor study identifier

790111

Secondary identifiers

79-C-0111

Study Type

interventional

Actual enrollment (reported)

256

Locations

1 country

Sites

1

Timeline

Study Start

September 4, 1979

Actual (reported)

Primary Completion

September 27, 2016

Actual (reported)

Study Completion

November 17, 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 256 participants
Study completion date: November 17, 2016
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 4, 1979
Actual (reported)
First Submitted
October 1, 2011
Actual (reported)
First Posted
November 10, 2011
Actual (reported)
Primary Completion
September 27, 2016
Actual (reported)
Study Completion
November 17, 2016
Actual (reported)

Last Updated: April 26, 2024
Status Verified: April 2024
Last Update Submitted: April 24, 2024

Conditions

Breast Cancer

Keywords

Breast CancerSurgeryRadiation

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

MProcedure

Modified radical mastectomy

M

XRadiation

Excisional biopsy plus radiation

X

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (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).

Sponsors & Collaborators

National Cancer Institute (NCI)
NIHlead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Kevin A Camphausen, M.D.
National Cancer Institute (NCI)
PRINCIPAL INVESTIGATOR

Enrollment

256 participants (actual enrollment reported by the registry).

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

Actual (reported)

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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.

Contact the study team to confirm eligibility.

Primary Completion

September 27, 2016

Actual (reported)

Study Completion

November 17, 2016

Actual (reported)

Last Updated

April 26, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01468883
Data provider: ClinicalTrials.gov
Source updated: 2024-04-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:58 UTC

Locations

US(1)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

M

X

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

M

X

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations