Breast Cancer
Conditions
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.
Interventions
PROCEDUREShave margins
Partial mastectomy with shave margins.
PROCEDURENo Shave Margins
Partial mastectomy without shave margins.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal surgical treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Cosmesis | 12 months | To determine the effect of routine shave margins on cosmesis |
| Operative time | 12 months | To determine the effect of routine shave margins on the time in the operating suite. |
| Volume of tissue resected | 12 months | To determine the effect of routine shave margins on the volume of tissue resected. |
Countries
United States
Outcome results
None listed