Shave Margins vs. Standard Partial Mastectomy for Breast Cancer
(SHAVE2 Trial)
Trial Summary
What is the purpose of this trial?
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.
Research Team
Anees Chagpar, MD
Principal Investigator
Yale University
Eligibility Criteria
This trial is for women aged 18 or older with stage 0-3 breast cancer who are suitable candidates for partial mastectomy. Participants must understand and agree to the study by signing a consent form. Women with metastatic disease, bilateral synchronous breast cancer, previous excisional biopsies, multicentric cancers requiring double lumpectomy, those receiving IORT, or with a history of breast cancer are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo partial mastectomy with randomization to either no shave margin or shave margin group
Follow-up
Participants are monitored for local recurrence, quality of life, and cosmesis
Treatment Details
Interventions
- Partial Mastectomy
- Partial Mastectomy with Additional Shave Margin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor