The Comparison Between M-E-BCS and C-O-BCS. (NCT07539545) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Comparison Between M-E-BCS and C-O-BCS.
China1,366 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion Criteria:
* 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. .
Exclusion Criteria:
* 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 mut…