Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients

NCT02648802 | Completed

• 1 other identifier: CSBCS1
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

breast-conserving surgery(BCS); Cavity shave margin; Proportion of positive margins

Outcome Measures

Primary Outcomes (1)

• Positivity rate of CMs by intraoperative frozen section analysis.

  Proportion of patients with at least one positive(invasive carcinoma or carcinoma in situ, excluding LCIS) CMs on intraoperative frozen section analysis

  Completion of surgery for all enrolled patients (approximately 12 months)

Secondary Outcomes (9)

• Intra-operative rate of suspected/positive CM

  Completion of surgery for all enrolled patients (approximately 12 months)

• Rate of intra-operative re-excision for suspected/positive CMs

  Completion of surgery for all enrolled patients (approximately 12 months)

• Rate of a second-time surgery for post-operative positive CMs

  Completion of surgery for all enrolled patients (approximately 12 months)

• Proportion of patients successfully undergone BCT

  Completion of surgery for all enrolled patients (approximately 12 months)

• Cost-effectiveness of cavity shaving in BCS as measured by operative time of the surgery

  Completion of surgery for all enrolled patients (approximately 12 months)

Other Outcomes (4)

• Volume of cavity shaving tissue.

  Completion of surgery for all enrolled patients (approximately 12 months)

• Weight of cavity shaving tissue.

  Completion of surgery for all enrolled patients (approximately 12 months)

• Relationship between the volume of tissue excised in association aesthetic outcomes

  Completion of surgery for all enrolled patients (approximately 12 months)

Study Arms (2)

Cavity shaving and CM assessment

EXPERIMENTAL

Standardized BCS with additional cavity shaving before CM assessment.

Procedure: Cavity shaving; Procedure: Standardized BCS+CM assessment.

CM assessment

PLACEBO COMPARATOR

Standardized BCS with CM assessment.

Procedure: Standardized BCS+CM assessment.

Interventions

Cavity shaving PROCEDURE

Resect the residual cavity circumferentially (superior, inferior, medial, lateral) and the thickness of the cavity shaving depends on the surgeon's discretion (Recommended 0.5-1.0cm). The principles of the cavity shaving includes: 1) do not compromise the cosmetic outcomes; 2) covers the entire cavity;

Cavity shaving and CM assessment

Standardized BCS+CM assessment. PROCEDURE

For standardized BCS(Chen K, et al. Ann Surg Oncol. 2012), we resect a rim of 1 cm macroscopically normal tissue around the tumor. The anterior and posterior margins of the tumor-containing specimen extended up to the subdermal plane of the skin and down to the pectoralis major fascia, respectively. The anterior and posterior CMs assessment will not be needed. A surgical blade was used for resecting the CMs (superior, inferior, medial and lateral) to render the thickness of the CMs as thin as possible. No procedures were required for distinguishing the inner and outer surface. They were then frozen and cut parallel, but not perpendicular to the largest surface area. CMs were defined as positive when in situ or invasive carcinoma was found intraoperatively by frozen-section analysis.

CM assessment; Cavity shaving and CM assessment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (9)

• Fisher 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 BACKGROUND

• Veronesi 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 BACKGROUND

• Moran 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 BACKGROUND

• Morrow 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 BACKGROUND

• Cendan 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 BACKGROUND

• Chagpar 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 BACKGROUND

• Kayar R, Civelek S, Cobanoglu M, Gungor O, Catal H, Emiroglu M. Five methods of breast volume measurement: a comparative study of measurements of specimen volume in 30 mastectomy cases. Breast Cancer (Auckl). 2011 Mar 27;5:43-52. doi: 10.4137/BCBCR.S6128.

  PMID: 21494401 BACKGROUND

• Chen K, Zeng Y, Jia H, Jia W, Yang H, Rao N, Song E, Cox CE, Su F. Clinical outcomes of breast-conserving surgery in patients using a modified method for cavity margin assessment. Ann Surg Oncol. 2012 Oct;19(11):3386-94. doi: 10.1245/s10434-012-2331-5. Epub 2012 Apr 10.

  PMID: 22488098 BACKGROUND

• Chen K, Zhu L, Chen L, Li Q, Li S, Qiu N, Yang Y, Su F, Song E. Circumferential Shaving of the Cavity in Breast-Conserving Surgery: A Randomized Controlled Trial. Ann Surg Oncol. 2019 Dec;26(13):4256-4263. doi: 10.1245/s10434-019-07725-w. Epub 2019 Aug 19.

  PMID: 31429019 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fengxi Su, M.D.

  Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Breast Tumor Department of Sun Yat-Sen Memorial Hospital

Study Record Dates

• First Submitted: January 3, 2016
• First Posted: January 7, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: August 20, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)