Clinical trial · Interventional
A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
NCT01452399CI-TRIAL-00049638completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Shave Margins | Procedure | — | UNRESOLVED |
| Shave margins | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Shave Margins
- interventionNames
- Procedure: Shave margins
- type
- ACTIVE_COMPARATOR
- label
- No shave margins
- interventionNames
- Procedure: No Shave Margins
Primary outcomes (1)
- measure
- Optimal surgical treatment
- timeFrame
- 12 months
- description
- 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
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDChagpar AB, Horowitz NR, Killelea BK, Tsangaris T, Longley P, Grizzle S, Loftus M, Li F, Butler M, Stavris K, Yao X, Harigopal M, Bossuyt V, Lannin DR, Pusztai L, Davidoff AJ, Gross CP. Economic Impact of Routine Cavity Margins Versus Standard Partial Mastectomy in Breast Cancer Patients: Results of a Randomized Controlled Trial. Ann Surg. 2017 Jan;265(1):39-44. doi: 10.1097/SLA.0000000000001799. PMID 27192352
- DERIVEDChagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30. PMID 26028131