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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: February 24, 2015
Last verified: February 2015
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:

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
Genders 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
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

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01452399     History of Changes
Other Study ID Numbers: 1107008825
Study First Received: September 29, 2011
Last Updated: February 24, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on March 02, 2015