About this trial
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
female patients, age≥18 year
A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
Patients pathologically diagnosed with untreated breast cancer by core-needle biopsy, with histologically confirmed non-palpable in situ cancer, including pleomorphic lobular carcinoma in situ or invasive non-palpable breast cancer that required localization
Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.
Disqualifiers
Inflammatory breast cancer or Paget's disease
Breast deformities and other conditions that impact breast conservation success rate
Patients with contraindications to breast-conserving surgery, as well as those with systemic diseases, mental disorders, or other subjective reasons that may affect their ability to participate in the trial. Patients with severe bleeding disorders or coagulation disorders were also excluded
Pregnancy or lactation
Trial design
Parallel
Treatments tested in this trial
Wire-guided localization and marker clip localization
Procedure/SurgeryPositioning guide wire and marker clip in the center of the lesion
Wire-guided localization
Procedure/SurgeryPositioning guide wire in the center of the lesion
Treatment groups
Trial outcomes
Primary outcomes
positive margin rate
It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.
Secondary outcomes
Re-operation rate
the proportion of patients which have a positive margin and requires reoperation
The proportion of breast-conserving surgery
It refers to the proportion of patients who have successfully undergone breast-conserving surgery.
IDFS
Time from surgery to the first occurrence of local, distant disease recurrence, or death.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.