NCT01452399

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

September 29, 2011

Last Update Submit

January 25, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Optimal surgical treatment

    To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates

    12 months

Secondary Outcomes (3)

  • Cosmesis

    12 months

  • Operative time

    12 months

  • Volume of tissue resected

    12 months

Study Arms (2)

Shave Margins

EXPERIMENTAL
Procedure: Shave margins

No shave margins

ACTIVE COMPARATOR
Procedure: No Shave Margins

Interventions

Shave marginsPROCEDURE

Partial mastectomy with shave margins.

Shave Margins
No Shave MarginsPROCEDURE

Partial mastectomy without shave margins.

No shave margins

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients who have received previous neoadjuvant chemotherapy
  • Patients who require a total mastectomy
  • Known metastatic breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

  • 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.

    PMID: 27192352DERIVED

  • 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.

    PMID: 26028131DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anees Chagpar, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 14, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

US(1)