Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer: a Prospective Randomized Control Trial.

Conditions
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Breast Cancer, Breast-conserving Surgery

Intervention / Treatment
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* Procedure: Wire-guided localization and marker clip localization
* Procedure: Wire-guided localization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion criteria: 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 Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment Patients with stage IV diseases or unresectable lesions in either breast Patients combined with other diseases that may affect survival Patients with multicentric breast cancer lesions or lesions > 5 cm in diameter on imaging examinations Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Untreated patients-combined localization<br>In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation | Procedure: Wire-guided localization and marker clip localization<br>* Positioning guide wire and marker clip in the center of the lesion<br>|
| Active Comparator: Untreated patients-single localization<br>In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation | Procedure: Wire-guided localization<br>* Positioning guide wire in the center of the lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-operation rate | the proportion of patients which have a positive margin and requires reoperation | up to 3 months after first operation | 
| The proportion of breast-conserving surgery | It refers to the proportion of patients who have successfully undergone breast-conserving surgery. | up to 3 months after first operation | 
| IDFS | Time from surgery to the first occurrence of local, distant disease recurrence, or death. | 2 years, 3 years, and 5 years |