Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients (SHAVE2)
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|ClinicalTrials.gov Identifier: NCT02772731|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2016
Last Update Posted : September 13, 2018
Breast cancer is the most common malignancy affecting women in the US. Surgical management is the mainstay of therapy, and in general consists of resection of the primary tumor with either a partial mastectomy (aka "lumpectomy") or a total mastectomy.
The investigators hypothesize that routine shave margins during partial mastectomy will significantly reduce positive margin rate. A positive margin means that cancerous cells were detected at the edge of the excised area. This generally mandates a return to the operating room for re-excision.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Partial mastectomy plus additional Shave Margin Procedure: Partial mastectomy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Multicenter Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||November 2021|
Experimental: Shave Margin
After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.
Procedure: Partial mastectomy plus additional Shave Margin
For the shave group, additional superior, inferior, medial and lateral margins will be removed, oriented, and sent for pathologic evaluation at the local site. Resection of additional anterior and posterior margins will be left to surgeon discretion, as this will depend on if skin or fascia was taken. All surgeons participating in the study will be educated on the expectation of what is considered a "shave margin". A shave margin is defined as an additional segment of breast tissue taken from each of the superior, inferior, medial, and lateral aspects of the cavity, such that the entire circumference of the cavity is re-excised following this procedure. Orientation of each shaved margin will be done to mark the true margin.
Active Comparator: No Shave Margin
After partial mastectomy, patients will be subject to intraoperative randomization to the no shave margin group, where after initial surgery, no further tissue will be removed.
Procedure: Partial mastectomy
Surgeons will be instructed to close after partial mastectomy with no further excision.
- Positive margin rate [ Time Frame: immediately after surgery ]The effect is positive margin rate post-surgery as measured by local pathological reports. Positive margins were defined as tumor touching the edge of the specimen that was removed in patients with invasive cancer and tumor that was within 2 mm of the edge of the specimen removed in those with ductal carcinoma in situ.
- local recurrence rates [ Time Frame: up to 5 years ]Patients will be assessed for local recurrence based on physical examination, mammography, and follow up phone calls. This is a composite score with only one outcome and only one unit (respondents). A positive results from any of these methods indicates recurrence.
- patient perceived cosmesis [ Time Frame: 1 year post-op ]Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.
- patient perceived cosmesis [ Time Frame: 5 years post-op ]Subjects will be asked their perception of physical appearance: poor, fair, good, or excellent.
- volume of tissue resected [ Time Frame: immediately after tissue resection ]based on the sum of the volumes of tissue excised as found in the gross description of the specimens on the pathology report.
- Quality of Life assessment [ Time Frame: 1 year post-op about the last seven days ]Quality of Life Questionnaire measures quality of life over the past 7 days and includes 75 questions that are answered on a Likert scale. Questions assess physical, social, emotional and functional well-being in addition to cosmetic and physical appearance and questions regarding the surgery. Higher scores indicate a higher quality of life.
- Quality of Life assessment [ Time Frame: 5 years post-op about the last seven days ]Quality of Life Questionnaire measures quality of life over the past 7 days and includes 75 questions that are answered on a Likert scale. Questions assess physical, social, emotional and functional well-being in addition to cosmetic and physical appearance and questions regarding the surgery. Higher scores indicate a higher quality of life.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772731
|United States, California|
|Loma Linda University Cancer Center|
|Loma Linda, California, United States, 92354|
|United States, Florida|
|Watson Clinic Cancer and Research Center|
|Lakeland, Florida, United States, 33805|
|United States, Michigan|
|William Beaumont Hospital|
|Troy, Michigan, United States, 48085|
|United States, North Carolina|
|UNC Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7213|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Cleveland Clinic Akron General|
|Akron, Ohio, United States, 44307|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, Rhode Island|
|Women & Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|United States, Texas|
|Doctors Hospital at Renaissance|
|Edinburg, Texas, United States, 78539|
|Principal Investigator:||Anees Chagpar, MD||Yale University|