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


N/A
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Optimal surgical treatment

Outcome Description:

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

Outcome Time Frame:

12 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

1107008825

NCT ID:

NCT01452399

Start Date:

October 2011

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Yale University School Of MedicineNew Haven, Connecticut  06520