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

Study Overview
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Brief Summary
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The standard method for localizing non-palpable breast cancer is currently clip localization, its positive margin rate still remains around 20-50%. This study aims to compare the accuracy and efficacy of single 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 After Neoadjuvant Therapy : 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: marker clip 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 breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment. 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 hook-wire, 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 Patients with history of ipsilateral breast cancer radical mastectomy 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: patients after neoadjuvant therapy-combined localization<br> | Procedure: Wire-guided localization and marker clip localization<br>* Positioning guide wire and marker clip in the center of the breast lesion<br>|
| Active Comparator: patients after neoadjuvant therapy-single localization<br> | Procedure: marker clip localization<br>* Positioning marker clip in the center of the breast lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal positive rate | Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer) | 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 a re-operation | up to 3 months | 
| The proportion of breast-conserving surgery. | It refers to the proportion of patients who have successfully undergone breast-conserving surgery. | up to 3 months | 
| IDFS | Time from surgery to the first occurrence of local, distant disease recurrence, or death. | 2 years, 3 years, and 5 years |