Breast Cancer, Breast-conserving Surgery
Conditions
Brief summary
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.
Detailed description
The standard method for localizing non-palpable breast cancer is currently preoperative wire-guided localization. This study aims to compare the accuracy and efficacy of wire vs. combined breast tissue markers in localizing non-palpable breast cancer.
Interventions
Positioning guide wire and marker clip in the center of the lesion
PROCEDUREWire-guided localization
Positioning guide wire in the center of the lesion
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. female patients, age≥18 year 2. A score of ≥ 2 on the Eastern Cooperative Oncology Group scale 3. 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 4. Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.
Exclusion criteria
1. Inflammatory breast cancer or Paget's disease 2. Breast deformities and other conditions that impact breast conservation success rate 3. 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 4. Pregnancy or lactation 5. Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment 6. Patients with stage IV diseases or unresectable lesions in either breast 7. Patients combined with other diseases that may affect survival 8. Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations 9. Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| positive margin rate | up to 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Re-operation rate | up to 3 months after first operation | the proportion of patients which have a positive margin and requires reoperation |
| The proportion of breast-conserving surgery | up to 3 months after first operation | It refers to the proportion of patients who have successfully undergone breast-conserving surgery. |
| IDFS | 2 years, 3 years, and 5 years | Time from surgery to the first occurrence of local, distant disease recurrence, or death. |
Countries
China
Contacts
Primary ContactChang Gong, doctor
Outcome results
None listed