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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT01452399

First received: September 29, 2011

Last updated: September 1, 2016

Last verified: September 2016

History of Changes

Purpose

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.

Condition	Intervention
Breast Cancer	Procedure: Shave margins Procedure: No Shave Margins


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Optimal surgical treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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

Secondary Outcome Measures:

Cosmesis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine the effect of routine shave margins on cosmesis
Operative time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine the effect of routine shave margins on the time in the operating suite.
Volume of tissue resected [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To determine the effect of routine shave margins on the volume of tissue resected.


Enrollment:	251
Study Start Date:	October 2011
Estimated Study Completion Date:	October 2016
Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Shave Margins	Procedure: Shave margins Partial mastectomy with shave margins.
Active Comparator: No shave margins	Procedure: No Shave Margins Partial mastectomy without shave margins.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452399

Locations


United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

Investigators


Principal Investigator:	Anees Chagpar, M.D.	The Breast Center -- Smilow Cancer Hospital at Yale-New Haven

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT01452399 History of Changes
Other Study ID Numbers:	1107008825
Study First Received:	September 29, 2011
Last Updated:	September 1, 2016
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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