A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients

NCT ID: NCT01452399

Last Updated: 2021-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2020-08-31

Brief Summary

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This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shave Margins

Group Type EXPERIMENTAL

Shave margins

Intervention Type PROCEDURE

Partial mastectomy with shave margins.

No shave margins

Group Type ACTIVE_COMPARATOR

No Shave Margins

Intervention Type PROCEDURE

Partial mastectomy without shave margins.

Interventions

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Shave margins

Partial mastectomy with shave margins.

Intervention Type PROCEDURE

No Shave Margins

Partial mastectomy without shave margins.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same.
2. Women ≥ 18 years of age.
3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Patients who have received previous neoadjuvant chemotherapy
2. Patients who require a total mastectomy
3. Known metastatic breast cancer.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anees Chagpar, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Breast Center -- Smilow Cancer Hospital at Yale-New Haven

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Chagpar AB, Horowitz NR, Killelea BK, Tsangaris T, Longley P, Grizzle S, Loftus M, Li F, Butler M, Stavris K, Yao X, Harigopal M, Bossuyt V, Lannin DR, Pusztai L, Davidoff AJ, Gross CP. Economic Impact of Routine Cavity Margins Versus Standard Partial Mastectomy in Breast Cancer Patients: Results of a Randomized Controlled Trial. Ann Surg. 2017 Jan;265(1):39-44. doi: 10.1097/SLA.0000000000001799.

Reference Type DERIVED
PMID: 27192352 (View on PubMed)

Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.

Reference Type DERIVED
PMID: 26028131 (View on PubMed)

Other Identifiers

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1107008825

Identifier Type: -

Identifier Source: org_study_id

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