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

Sun Yat-sen University

Status: Enrolling

Conditions: Breast Cancer; Breast-conserving Surgery

Treatments: Procedure: Wire-guided localization; Procedure: Wire-guided localization and marker clip localization

Study type: Interventional

Funder types: Other

Identifiers

NCT05797454

SYSKY-2023-129-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Untreated patients-combined localization

Experimental group

Description:

In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation

Treatment:

Procedure: Wire-guided localization and marker clip localization

Untreated patients-single localization

Active Comparator group

Description:

In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation

Treatment:

Procedure: Wire-guided localization