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

Not Applicable

Recruiting

• Conditions: Breast Cancer; Breast-conserving Surgery
• Interventions: Procedure: Wire-guided localization and marker clip localization; Procedure: Wire-guided localization

• Registration Number: NCT05797454
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-02-26
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 170

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Untreated patients-combined localization	Wire-guided localization and marker clip localization	In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation
Untreated patients-single localization	Wire-guided localization	In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
IDFS	2 years, 3 years, and 5 years	Time from surgery to the first occurrence of local, distant disease recurrence, or death.
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.
Re-operation rate	up to 3 months after first operation	the proportion of patients which have a positive margin and requires reoperation

Trial Locations

Locations (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China