The Comparison Between M-E-BCS and C-O-BCS.

NCT07539545 | Not Yet Recruiting DMC

• 1 other identifier: 2025(1479)
• Study Type: interventional
• Target: 1,366
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival) between patients undergoing M-E-BCS and patients undergoing C-O-BCS.

Conditions

Breast Cancer

Keywords

Breast Cancer; Endoscopic surgery; Minimal invasive surgery; Breast-conserving Surgery

Outcome Measures

Primary Outcomes (1)

• Local recurrence rates

  The risk of local recurrence within five years.

  Postoperative 5 years

Secondary Outcomes (16)

• Surgical efficiency

  Intraoperative

• Economic effect

  1 month postoperative

• Surgical safety

  Intraoperative, 3 months postoperative.

• Aesthetic outcomes (BREAST-Q score)

  Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.

• Aesthetic outcome (Harris score)

  Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.

Study Arms (2)

Intervention group

EXPERIMENTAL

Minimal accessory-incision-assisted endoscopic breast-conserving surgery

Procedure: Minimal accessory-incision-assisted endoscopic breast-conserving surgery

Control group

EXPERIMENTAL

Conventional open breast-conserving surgery

Procedure: Conventional open breast-conserving surgery

Interventions

Minimal accessory-incision-assisted endoscopic breast-conserving surgery PROCEDURE

A small incision was made in the concealed area of the armpit, and a endoscopic device was inserted. Under direct vision, the tumor was precisely removed and the lymph nodes in the armpit were cleared layer by layer. The incision was then sutured layer by layer, and a drainage tube was placed after the operation.

Intervention group

Conventional open breast-conserving surgery PROCEDURE

Conventional open breast-conserving surgery is a surgical approach that aims to preserve the appearance and function of the breast as much as possible while ensuring the complete removal of the tumor. It is suitable for eligible patients with early-stage breast cancer and requires comprehensive postoperative treatment measures such as radiotherapy.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients aged 18-70 years (inclusive);
• preoperative pathological examination confirmed it as invasive breast cancer or ductal carcinoma in situ;
• both clinical and imaging examinations clearly indicated that the lesion was a single lesion confined within the gland, without invasion of the skin, subcutaneous tissue, pectoralis major muscle, or the nipple-areola complex;
• tumors in the inner and outer quadrants (three classification method, as shown in Figure 2);
• preoperative tumor size ≤3 cm (pre-neoadjuvant chemotherapy if applicable);
• the tumor is more than 2 cm away from the nipple (the distance is based on physical examination, with MRI and ultrasound as supplementary methods);
• the patient has a clear intention to preserve the breast and can receive standard radiotherapy after the operation;
• voluntary provision of informed consent. .

You may not qualify if:

• clinically or radiologically evaluated as multifocal or multicentric breast cancer, with diffuse suspicious calcification, long spiculated masses, extensive local resection unable to obtain sufficient negative margins or ideal shape;
• persistent positive tumor margins, and resection cannot ensure negative margins after resection;
• inflammatory breast cancer;
• pregnant and lactating women;
• previous history of breast cancer surgery (including patients with recurrence after ipsilateral breast-conserving surgery);
• breast cancer genetic gene mutations (such as BRCA1/2 gene mutations);
• preoperative severe underlying diseases that cannot tolerate general anesthesia and surgical procedures.
• other situations that the researchers consider unsuitable for participation

Sponsors & Collaborators

• Du Zhenggui: lead
• West China Fourth Hospital of Sichuan University: collaborator
• West China Second University Hospital: collaborator
• The Fourth People's Hospital of Sichuan Province: collaborator
• Taiyuan Central Hospital of Shanxi Medical University: collaborator
• Chengdu Second people's hospital: collaborator
• Suzhou Municipal Hospital: collaborator

Study Sites (1)

West China hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

Related Publications (12)

• Schumacher JR, Wiener AA, Greenberg CC, Hanlon B, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher JG, Yu M, Vanness DJ, Yang DY, Havlena J, Strand C, Neuman HB. Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01). Ann Surg. 2023 May 1;277(5):841-845. doi: 10.1097/SLA.0000000000005776. Epub 2022 Dec 14.

  PMID: 36521077 RESULT

• Liang Y, Xu S. Nonliposuction Endoscopic Sentinel Lymph Node Biopsy Through the Periareolar Incision. Surg Innov. 2020 Dec;27(6):570-579. doi: 10.1177/1553350620942983. Epub 2020 Jul 20.

  PMID: 32687735 RESULT

• Mok CW, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast. 2019 Aug;46:144-156. doi: 10.1016/j.breast.2019.05.013. Epub 2019 May 20.

  PMID: 31176887 RESULT

• Patrianagara A, Hwei LRY. Endoscopy-assisted breast conservation surgery (E-BCS) vs conventional breast conservation surgery (C-BCS) technique for the management of early breast cancer: A systematic review and meta-analysis. Breast Dis. 2023;42(1):383-393. doi: 10.3233/BD-230023.

  PMID: 38108340 RESULT

• Lai HW, Chen ST, Liao CY, Mok CW, Lin YJ, Chen DR, Kuo SJ. Oncologic Outcome of Endoscopic Assisted Breast Surgery Compared with Conventional Approach in Breast Cancer: An Analysis of 3426 Primary Operable Breast Cancer Patients from Single Institute with and Without Propensity Score Matching. Ann Surg Oncol. 2021 Nov;28(12):7368-7380. doi: 10.1245/s10434-021-09950-8. Epub 2021 May 11.

  PMID: 33974198 RESULT

• Takahashi H, Fujii T, Nakagawa S, Inoue Y, Akashi M, Toh U, Iwakuma N, Takahashi R, Takenaka M, Fukuma E, Shirouzu K. Usefulness of endoscopic breast-conserving surgery for breast cancer. Surg Today. 2014 Nov;44(11):2037-44. doi: 10.1007/s00595-013-0767-2. Epub 2013 Oct 24.

  PMID: 24150099 RESULT

• Ozaki S, Ohara M, Shigematsu H, Sasada T, Emi A, Masumoto N, Kadoya T, Murakami S, Kataoka T, Fujii M, Arihiro K, Okada M. Technical feasibility and cosmetic advantage of hybrid endoscopy-assisted breast-conserving surgery for breast cancer patients. J Laparoendosc Adv Surg Tech A. 2013 Feb;23(2):91-9. doi: 10.1089/lap.2012.0224. Epub 2012 Dec 28.

  PMID: 23272727 RESULT

• Haloua MH, Krekel NM, Winters HA, Rietveld DH, Meijer S, Bloemers FW, van den Tol MP. A systematic review of oncoplastic breast-conserving surgery: current weaknesses and future prospects. Ann Surg. 2013 Apr;257(4):609-20. doi: 10.1097/SLA.0b013e3182888782.

  PMID: 23470508 RESULT

• Murugappan K, Saboo A, Kuo L, Ung O. Paradigm shift in the local treatment of breast cancer: mastectomy to breast conservation surgery. Gland Surg. 2018 Dec;7(6):506-519. doi: 10.21037/gs.2018.09.01.

  PMID: 30687624 RESULT

• Johns N, Dixon JM. Should patients with early breast cancer still be offered the choice of breast conserving surgery or mastectomy? Eur J Surg Oncol. 2016 Nov;42(11):1636-1641. doi: 10.1016/j.ejso.2016.08.016. Epub 2016 Aug 31.

  PMID: 27665053 RESULT

• De La Cruz L, Blankenship SA, Chatterjee A, Geha R, Nocera N, Czerniecki BJ, Tchou J, Fisher CS. Outcomes After Oncoplastic Breast-Conserving Surgery in Breast Cancer Patients: A Systematic Literature Review. Ann Surg Oncol. 2016 Oct;23(10):3247-58. doi: 10.1245/s10434-016-5313-1. Epub 2016 Jun 29.

  PMID: 27357177 RESULT

• Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer. 2020 Jul;27(4):534-566. doi: 10.1007/s12282-020-01076-1. Epub 2020 Mar 12.

  PMID: 32162181 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhenggui Du Du

CONTACT

+86 13880768222; docduzg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director. Zhenggui Du

Study Record Dates

• First Submitted: March 15, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 20, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of relevant research outputs, such as academic papers and books.
• Access Criteria: When a request has been approved, the investigator will provide access to the de-identified individual patient-level data in the data management platform (Electronic Data Capture, EDC). A signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing the requested information. Additionally, all users will need to accept the terms and conditions of the data management platform to gain access.

Locations

CN (1)