This trial is active, not recruiting.

Condition breast cancer
Treatments shave margins, no shave margins
Sponsor Yale University
Start date October 2011
End date August 2014
Trial size 251 participants
Trial identifier NCT01452399, 1107008825


This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
shave margins
Partial mastectomy with shave margins.
(Active Comparator)
no shave margins
Partial mastectomy without shave margins.

Primary Outcomes

Optimal surgical treatment
time frame: 12 months

Secondary Outcomes

time frame: 12 months
Operative time
time frame: 12 months
Volume of tissue resected
time frame: 12 months

Eligibility Criteria

Female participants from 18 years up to 90 years old.

Inclusion Criteria: 1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same. 2. Women ≥ 18 years of age. 3. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who have received previous neoadjuvant chemotherapy 2. Patients who require a total mastectomy 3. Known metastatic breast cancer.

Additional Information

Official title A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
Principal investigator Anees Chagpar, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Yale University.