Clinical trial · Interventional
Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
A Multicenter Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients
- 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)
Breast cancer is the most common malignancy affecting women in the US. Surgical management is the mainstay of therapy, and in general consists of resection of the primary tumor with either a partial mastectomy (aka "lumpectomy") or a total mastectomy. The investigators hypothesize that routine shave margins during partial mastectomy will significantly reduce positive margin rate. A positive margin means that cancerous cells were detected at the edge of the excised area. This generally mandates a return to the operating room for re-excision.
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 |
|---|---|---|---|
| Partial mastectomy | Procedure | — | UNRESOLVED |
| Partial mastectomy plus additional Shave Margin | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Shave Margin
- description
- After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.
- interventionNames
- Procedure: Partial mastectomy plus additional Shave Margin
- type
- ACTIVE_COMPARATOR
- label
- No Shave Margin
- description
- 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.
- interventionNames
- Procedure: Partial mastectomy
Primary outcomes (1)
- measure
- Positive margin rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 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. Exlusion Criteria 1. Total mastectomy 2. Known metastatic disease 3. Bilateral synchronous breast cancer 4. Multicentric cancers requiring double lumpectomy 5. Previous history of breast cancer (even in the other breast) 6. Patients receiving Intraoperative radiation therapy (IORT) 7. Patients who had excisional biopsy for diagnosis of their cancer (I.e., instead of a core biopsy)
References
Publications (1)
- BACKGROUNDChagpar 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