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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797454
• Other study ID #: SYSKY-2023-129-01
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Chang Gong, doctor
• Phone: 02034070499
• Email: changgong282[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast-conserving Surgery

Intervention

Procedure:
• Wire-guided localization and marker clip localization
Positioning guide wire and marker clip in the center of the lesion
• Wire-guided localization
Positioning guide wire in the center of the lesion

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive margin rate	It is defined as the proportion of patients in whom in situ or invasive carcinoma is found in the cavity margins after the first resection, including intraoperative frozen-section analysis and postoperative formalin-fixed paraffin-embedded analysis, subject to postoperative analysis.	up to 3 months
Secondary	Re-operation rate	the proportion of patients which have a positive margin and requires reoperation	up to 3 months after first operation
Secondary	The proportion of breast-conserving surgery	It refers to the proportion of patients who have successfully undergone breast-conserving surgery.	up to 3 months after first operation
Secondary	IDFS	Time from surgery to the first occurrence of local, distant disease recurrence, or death.	2 years, 3 years, and 5 years