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Shave Margins vs. Standard Partial Mastectomy for Breast Cancer (SHAVE2 Trial)

N/A

Waitlist Available

Led By Anees Chagpar, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same

Be older than 18 years old

Must not have

Known metastatic disease

Bilateral synchronous breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not shaving margins during a partial mastectomy will reduce the rate of positive margins.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, typical risks associated with surgical procedures may include pain at the surgery site, infection risk, bleeding complications and potential impacts on physical appearance where tissue was removed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have stage 0-3 breast cancer and am a candidate for partial mastectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I have cancer in both breasts at the same time.

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I have had a total mastectomy.

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I had a surgical biopsy to diagnose my cancer.

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I need surgery to remove multiple tumors in my breast.

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I have had breast cancer before, even in the other breast.

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I am receiving radiation therapy during surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positive margin rate

Secondary study objectives

Quality of Life assessment

local recurrence rates

patient perceived cosmesis

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met