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

Starting soon · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT07539545

Run by

Du Zhenggui

People needed

1366

Starts

2026-04-01

Expected to finish

2032-12-31

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• West China hospital of Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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