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

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ClinicalTrials.gov Identifier: NCT01452399
Recruitment Status : Active, not recruiting
First Posted : October 14, 2011
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Shave margins Procedure: No Shave Margins Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
Study Start Date : October 2011
Actual Primary Completion Date : August 2014
Estimated Study Completion Date : October 2020

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Optimal surgical treatment [ Time Frame: 12 months ]
    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 :
  1. Cosmesis [ Time Frame: 12 months ]
    To determine the effect of routine shave margins on cosmesis

  2. Operative time [ Time Frame: 12 months ]
    To determine the effect of routine shave margins on the time in the operating suite.

  3. Volume of tissue resected [ Time Frame: 12 months ]
    To determine the effect of routine shave margins on the volume of tissue resected.


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

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01452399     History of Changes
Other Study ID Numbers: 1107008825
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases