A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
N/A
18 Years
90 Years
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
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 Medicine | New Haven, Connecticut 06520 |
