400 Participants Needed

Shave Margins vs. Standard Partial Mastectomy for Breast Cancer

(SHAVE2 Trial)

Recruiting at 8 trial locations
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

AC

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

I have stage 0-3 breast cancer and am a candidate for partial mastectomy.
I am a woman aged 18 or older.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

I am receiving radiation therapy during surgery.
I had a surgical biopsy to diagnose my cancer.
I need surgery to remove multiple tumors in my breast.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo partial mastectomy with randomization to either no shave margin or shave margin group

Immediate
1 visit (in-person)

Follow-up

Participants are monitored for local recurrence, quality of life, and cosmesis

5 years
Regular follow-up visits and phone calls

Treatment Details

Interventions

  • Partial Mastectomy
  • Partial Mastectomy with Additional Shave Margin
Trial Overview The study is testing if taking additional tissue around the tumor (shave margins) during partial mastectomy reduces the chance of leaving behind any cancer cells compared to just the standard procedure. The goal is to see if this approach decreases the need for additional surgeries.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Shave MarginExperimental Treatment1 Intervention
After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.
Group II: No Shave MarginActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+
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