Clinical trial · Interventional
Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients
Cavity Shaving in Breast Conserving Surgery With Intraoperative Cavity Margin Assessment: A Single Center,Randomized,Controlled Trial
- 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 randomized controlled trial is to evaluate the impact of additional cavity shaving (CS) on pathological cavity margin (CM) status in breast cancer patients. Patients receiving standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment versus intra-operative CS followed by CM assessment. The primary objective of this study is to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate, post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time and medical costs.
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 |
|---|---|---|---|
| Cavity shaving | Procedure | — | UNRESOLVED |
| Standardized BCS+CM assessment. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cavity shaving and CM assessment
- description
- Standardized BCS with additional cavity shaving before CM assessment.
- interventionNames
- Procedure: Cavity shaving
- Procedure: Standardized BCS+CM assessment.
- type
- PLACEBO_COMPARATOR
- label
- CM assessment
- description
- Standardized BCS with CM assessment.
- interventionNames
- Procedure: Standardized BCS+CM assessment.
Primary outcomes (1)
- measure
- Positivity rate of CMs by intraoperative frozen section analysis.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female * At least 18 years of age and no more than 65 years of age * Able to understand and willing to sign an informed consent document * Willing and planning to undergo the breast-conserving surgery * ECOG≤ 2 Exclusion Criteria: * Inflammatory breast cancer * Preference for mastectomy instead of breast-conserving surgery * Necessity to undergo oncoplastic breast surgery * Prior surgical treatment, including ultrasound-guided vacuum-assisted biopsy and excision biopsy. * Prior systemic therapy for this diagnosis, including neoadjuvant chemotherapy, neoadjuvant endocrine therapy. * History of prior breast/axillary radiation therapy * Known metastatic disease * Diagnosed as bilateral breast cancer or DCIS * History of other malignancy ≤ 5 years previous * Preoperation evaluation indicates tumor size\>5cm * Preoperation evaluation indicates multicenter or multifocal breast cancer(including suspicious calcification on mammography) * Undergoing other clinical trials * With sever liver disfunction(Child-Pugh C) * With sever cardiac insufficiency * With sever renal disfunction * Pregnancy
References
Publications (9)
- BACKGROUNDFisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. PMID 12393820
- BACKGROUNDVeronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989. PMID 12393819
- BACKGROUNDMoran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):553-64. doi: 10.1016/j.ijrobp.2013.11.012. PMID 24521674
- BACKGROUNDMorrow M, Jagsi R, Alderman AK, Griggs JJ, Hawley ST, Hamilton AS, Graff JJ, Katz SJ. Surgeon recommendations and receipt of mastectomy for treatment of breast cancer. JAMA. 2009 Oct 14;302(14):1551-6. doi: 10.1001/jama.2009.1450. PMID 19826024
- BACKGROUNDCendan JC, Coco D, Copeland EM 3rd. Accuracy of intraoperative frozen-section analysis of breast cancer lumpectomy-bed margins. J Am Coll Surg. 2005 Aug;201(2):194-8. doi: 10.1016/j.jamcollsurg.2005.03.014. PMID 16038815
- 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.