Breast Margin Study: Routine Cavity Shave Margins Vs. Selective Margins Using Savi Scout®

Summary

This is a prospective study comparing partial mastectomy performed with routine cavity shave margins and Savi Scout® localization to partial mastectomy performed with selective margins and Savi Scout® localization. The primary objective is to determine the difference in positive margin rate between the two methods. The secondary objectives are to determine the differences in the rate of re-excision, volume of tissue extracted and Breast-Q® score between the two methods. It is hypothesized that the Savi Scout® will allow for decreased volume of tissue excised when compared to routine cavity shave margins without any difference in positive margin rate or rate of re-excision.

Eligibility

Inclusion Criteria

* Women 18 years and older, and
* With Clinical stage I-II invasive breast cancer, or Stage 0 DCIS, and
* That have been diagnosed by means of core needle biopsy appropriate for breast conserving therapy, and
* Present to Cleveland Clinic Akron General.
* Subjects must have pathologically confirmed breast carcinoma or ductal carcinoma in situ.
* Performance status: ECOG 0-1
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* Patients may have received or may be receiving endocrine therapy.

Exclusion Criteria

* Men
* Pregnant women
* Patients who have received neoadjuvant chemotherapy for current cancer diagnosis.
* Patients with current diagnosis of synchronous bilateral breast cancer. (A diagnosis of breast cancer at least one year prior to current cancer diagnosis is acceptable.)
* Patients \< 18 years of age.

Conditions2

Locations1 site

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