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

Not Applicable

Recruiting

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

• Registration Number: NCT05838001
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-16
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-05-01
• 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: 110

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 breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment.
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 hook-wire, 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
10. Patients with history of ipsilateral breast cancer radical mastectomy or chest wall radiotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients after neoadjuvant therapy-combined localization	Wire-guided localization and marker clip localization	-
patients after neoadjuvant therapy-single localization	marker clip localization	-

Primary Outcome Measures

Name	Time	Method
Marginal positive rate	up to 3 months	Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)

Secondary Outcome Measures

Name	Time	Method
Re-operation rate.	up to 3 months	the proportion of patients which have a positive margin and requires a re-operation
The proportion of breast-conserving surgery.	up to 3 months	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.

Trial Locations

Locations (1)

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