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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSHAVE2 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.
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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
Eligibility Criteria:
This trial includes the following eligibility 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.I have had breast cancer before, even in the other breast.My cancer has spread to other parts of my body.I have cancer in both breasts at the same time.I have had a total mastectomy.I have stage 0-3 breast cancer and am a candidate for partial mastectomy.I am a woman aged 18 or older.
Research Study Groups:
This trial has the following groups:- Group 1: Shave Margin
- Group 2: No Shave Margin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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