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

Sun Yat-sen University

Status: Enrolling

Conditions: Breast Cancer; Breast-conserving Surgery

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05838001

SYSKY-2023-129-02

Details and patient eligibility

About

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.

Enrollment: 110 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

patients after neoadjuvant therapy-combined localization

Experimental group

Treatment:

Procedure: Wire-guided localization and marker clip localization

patients after neoadjuvant therapy-single localization

Active Comparator group

Treatment:

Procedure: marker clip localization