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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838001
• Other study ID #: SYSKY-2023-129-02
• 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• 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 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

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 breast lesion
• marker clip localization
Positioning marker clip in the center of the breast lesion

Locations

Country	Name	City	State
China	Sun Yat-sen University Sun Yat-sen Memorial Hospital	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	Marginal positive rate	Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)	up to 3 months
Secondary	Re-operation rate.	the proportion of patients which have a positive margin and requires a re-operation	up to 3 months
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
Secondary	IDFS	Time from surgery to the first occurrence of local, distant disease recurrence, or death.	2 years, 3 years, and 5 years