Comparing localization methods for non-palpable breast cancer after treatment

Efficacy and Accuracy of Combined Localization Versus Single Localization in Non-palpable Breast Cancer After Neo-adjuvant Therapy : a Prospective Randomized Control Trial.

This study is testing whether using a combination of methods to locate non-palpable breast cancer after treatment works better than using just one method to help improve surgery results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05838001 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and precision of using combined localization techniques versus single localization methods for non-palpable breast cancer following neoadjuvant therapy. The standard approach, clip localization, has a significant positive margin rate, prompting the need for this comparison. Participants will undergo either wire-guided localization or marker clip localization to determine which method yields better surgical outcomes. The study aims to improve the accuracy of tumor localization, potentially leading to better surgical results.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 and older who have been diagnosed with non-palpable breast cancer and are willing to undergo breast-conserving surgery.

Not a fit: Patients with inflammatory breast cancer, those with contraindications to breast-conserving surgery, or those who have previously undergone localization techniques may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced positive margin rates for patients with non-palpable breast cancer.

How similar studies have performed: While the standard localization method has been widely used, this study's comparison of combined versus single localization techniques is a novel approach that has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Chang Gong, doctor

Conditions Breast Cancer; Breast-conserving Surgery