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Partial mastectomy plus additional Shave Margin 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
Women ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

SHAVE2 Trial 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.Check my eligibility
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.See study design
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.

SHAVE2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have stage 0-3 breast cancer and am a candidate for partial mastectomy.
Select...
I am a woman aged 18 or older.

SHAVE2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive margin rate
Secondary outcome measures
Quality of Life assessment
local recurrence rates
patient perceived cosmesis
+1 more

SHAVE2 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.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,837 Previous Clinical Trials
2,728,013 Total Patients Enrolled
26 Trials studying Breast Cancer
2,835 Patients Enrolled for Breast Cancer
Anees Chagpar, MDPrincipal InvestigatorYale University

Media Library

Partial Mastectomy Clinical Trial Eligibility Overview. Trial Name: NCT02772731 — N/A
Breast Cancer Research Study Groups: Shave Margin, No Shave Margin
Breast Cancer Clinical Trial 2023: Partial Mastectomy Highlights & Side Effects. Trial Name: NCT02772731 — N/A
Partial Mastectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02772731 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical centers are actively conducting this trial?

"This clinical trial is being conducted at 9 different sites, situated in cities across the country such as Loma Linda, Akron and Troy. To minimize any travel demands associated with enrollment, participants should look for a site located nearby their area of residence."

Answered by AI

Are there any vacancies left for participation in this clinical trial?

"Clinicaltrials.gov states that this test, which was initially posted on July 1st 2016 and last updated February 10th 2022 is no longer actively recruiting participants. Nonetheless, there are 2,603 other trials presently searching for volunteers."

Answered by AI
~46 spots leftby Mar 2025