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Completed

NCT Number: NCT01452399

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shave margins

Procedure

Partial mastectomy with shave margins.

No Shave Margins

Procedure

Partial mastectomy without shave margins.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2020
First posted
Oct 14, 2011
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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