Shave Margins vs. Standard Partial Mastectomy for Breast Cancer

(SHAVE2 Trial)

No longer recruiting at 8 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Metastatic disease, Bilateral cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding an extra step during a partial mastectomy (breast-conserving surgery) can reduce the likelihood of needing additional surgery later. The extra step involves removing more tissue around the tumor, known as shave margins, to help ensure no cancer cells remain. The trial compares this method to standard surgery without the extra step. Women with stage 0 to 3 breast cancer planning to undergo a partial mastectomy might be suitable candidates for this trial. As an unphased study, it offers participants the chance to contribute to innovative surgical techniques that could enhance future breast cancer surgeries.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical technique is safe for breast cancer patients?

Research has shown that using shave margins during a partial mastectomy can help ensure no cancerous cells remain at the edges of the removed tissue, potentially reducing the need for repeat surgeries. Studies have found that adding shave margins is generally well-tolerated by patients, with no significant increase in complications compared to the standard partial mastectomy.

For instance, one study found that the need for another surgery was slightly lower in the group that had shave margins, suggesting that the procedure is at least as safe as the standard surgery. Overall, these findings indicate that shave margins are a safe option for those undergoing partial mastectomy for breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing shave margins to standard partial mastectomy because it could enhance surgical outcomes for breast cancer patients. Unlike the typical partial mastectomy where only the visible tumor is removed, the shave margin technique involves taking additional tissue around the tumor site. This extra step might help reduce the likelihood of cancer cells being left behind, potentially lowering the risk of cancer recurrence. By exploring this method, researchers hope to improve long-term results for patients while maintaining cosmetic outcomes.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare the outcomes of partial mastectomy with and without additional shave margins. Research has shown that using shave margins during a partial mastectomy can reduce the chance of leaving cancer cells behind. When cancer cells appear at the edge of the removed tissue, another surgery is often necessary. A review of several studies found that adding cavity shave margins significantly lowered the rate of leftover cancer cells and the need for further surgery. Specifically, one study showed that patients who had cavity shaving had a 17.1% chance of leftover cancer cells, compared to 28.7% for those who did not. This indicates that the additional shave margin technique can help ensure more cancer-free tissue after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Anees Chagpar, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Shave Margin Experimental Treatment 1 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 Margin Active Control 1 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5605915/

Economic Impact of Routine Cavity Margins Versus ... The aim of the study was to compare costs associated with excision of routine cavity shave margins (CSM) versus standard partial mastectomy (PM) in patients ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02772731

Shave Margins vs. Standard Partial Mastectomy in Breast ... 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 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820921000586

Breast-Conserving Surgeries With and Without Cavity ... This study assesses the effectiveness of standard partial mastectomy with cavity shave margins (CSM) compared with partial mastectomy with selective margin ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0168705

A Systematic Review and Meta-Analysis | PLOS One In conclusion, our meta-analysis confirmed that additional CS was effective in reducing margin involvement and the reoperation rate when compared with partial ...

5. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1403069/full

Impact of cavity shave margins in patients with ductal ... Results: In patients subjected to cavity shaving, we reported a significant reduction in positive margins of 17.1% versus 28.7% (p-value = 0.042) ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa1504473

A Randomized, Controlled Trial of Cavity Shave Margins in ... We found that excision of a cavity shave margin reduced the rate of positive margins by nearly 50% and more than halved the rate of reexcision, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960740425001306

Cavity shave technique for safe resection margins in breast ... The rate of positive margins was 20.9% versus 18.1%, p-value:0.631 vs p-value:0.577. The re-excision rate was 12.1% vs 14.9%, in the CS-group ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10814307/

Cavity Shave Margins in Breast Conservative Surgery a ... Cases with positive margins were 23 (5.6%) in the control group (p = 0.846). In the cavity shave group, 164 (91.1%) patients had negative ...