Comparing methods for locating non-palpable breast cancer

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

This study is testing two different ways to find non-palpable breast cancer before surgery to see which method helps doctors locate tumors more accurately and improves patient outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 170 (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: NCT05797454 on ClinicalTrials.gov

What this trial studies

This study compares the effectiveness of two localization methods for non-palpable breast cancer: traditional wire-guided localization and a combined approach using breast tissue markers. The aim is to determine which method provides greater accuracy and efficacy in locating tumors prior to surgery. By evaluating the positive margin rates associated with each technique, the study seeks to improve surgical outcomes for patients undergoing breast-conserving surgery.

Who should consider this trial

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

Not a fit: Patients with inflammatory breast cancer, Paget's disease, or those with contraindications to breast-conserving surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate localization of breast tumors, potentially reducing the rate of positive margins and improving surgical outcomes.

How similar studies have performed: Other studies have explored localization techniques in breast cancer, but this specific comparison of wire-guided versus combined localization methods is novel.

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 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

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Chang Gong, doctor

Conditions Breast Cancer; Breast-conserving Surgery