Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02772731
- Run by
- Yale University
- People needed
- 400
- Starts
- 2016-07-01
- Expected to finish
- 2024-11-01
- Last updated by the study team
- 2025-01-31
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same
- Women ≥ 18 years of age
- Ability to understand and the willingness to sign a written informed consent document.
- Exlusion Criteria
- Total mastectomy
- Known metastatic disease
- Bilateral synchronous breast cancer
- Multicentric cancers requiring double lumpectomy
- Previous history of breast cancer (even in the other breast)
- Patients receiving Intraoperative radiation therapy (IORT)
- Patients who had excisional biopsy for diagnosis of their cancer (I.e., instead of a core biopsy)
Where it is running
- Loma Linda University Cancer Center — Loma Linda, California, United States
- Watson Clinic Cancer and Research Center — Lakeland, Florida, United States
- William Beaumont Hospital — Troy, Michigan, United States
- UNC Chapel Hill — Chapel Hill, North Carolina, United States
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States
- Cleveland Clinic Akron General — Akron, Ohio, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Women & Infants Hospital — Providence, Rhode Island, United States
- Doctors Hospital at Renaissance — Edinburg, Texas, United States
Full record on ClinicalTrials.gov
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