The Comparison Between M-E-BCS and C-O-BCS.
ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorDu Zhenggui
About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Minimal accessory-incision-assisted endoscopic breast-conserving surgery
- Conventional open breast-conserving surgery
Treatment groups
1,366 Participants
are divided into 2 treatment groupsSponsors and collaborators
Du Zhenggui
Lead sponsor
West China Hospital
Sponsor institution
West China Fourth Hospital
Collaborator
West China Second University Hospital
Collaborator
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
Source ClinicalTrials.gov