RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

PROCEDURE

Arm 1 Partial mastectomy with Savi Scout® localization and shave margins.

Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 1 randomization, the surgeons will be instructed to perform a partial mastectomy with routine cavity shave margins using Savi Scout® localization. The lesion will be removed in the routine fashion. The surgeons will use the Savi Scout® to perform routine cavity shave margins by extracting superior, lateral, inferior, medial, anterior, and posterior margins.

PROCEDURE

Arm 2 Partial mastectomy with Savi Scout® localization and selective shave margins.

Patients will undergo preoperative Savi Scout® reflector placement under image guidance per routine care. Patients will undergo randomization. With Arm 2 randomization, the surgeons will be instructed to perform a partial mastectomy with selective margins shave margins using Savi Scout®. The lesion will be removed in the routine fashion. The Savi Scout® localizer will be utilized to determine selective shave margins by examining the same margins on the excised tissue specimen. The surgeon will obtain selective margins if the margin of the tissue specimen is within 1mm of invasive cancer and 2mm within DCIS.

Locations (1)

Cleveland Clinic Akron General, Case Comprehensive Cancer Center

Akron, Ohio, United States