A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT01452399 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 14, 2011
Last Update Posted
: October 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Procedure: Shave margins Procedure: No Shave Margins | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 251 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | August 2014 |
Estimated Study Completion Date : | October 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Shave Margins |
Procedure: Shave margins
Partial mastectomy with shave margins.
|
Active Comparator: No shave margins |
Procedure: No Shave Margins
Partial mastectomy without shave margins.
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- Optimal surgical treatment [ Time Frame: 12 months ]To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates
- Cosmesis [ Time Frame: 12 months ]To determine the effect of routine shave margins on cosmesis
- Operative time [ Time Frame: 12 months ]To determine the effect of routine shave margins on the time in the operating suite.
- Volume of tissue resected [ Time Frame: 12 months ]To determine the effect of routine shave margins on the volume of tissue resected.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same.
- Women ≥ 18 years of age.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients who have received previous neoadjuvant chemotherapy
- Patients who require a total mastectomy
- Known metastatic breast cancer.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452399
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Anees Chagpar, M.D. | The Breast Center -- Smilow Cancer Hospital at Yale-New Haven |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01452399 History of Changes |
Other Study ID Numbers: |
1107008825 |
First Posted: | October 14, 2011 Key Record Dates |
Last Update Posted: | October 18, 2017 |
Last Verified: | October 2017 |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |