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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast-conserving Surgery
• Intervention / Treatment: Procedure: Wire-guided localization and marker clip localization; Procedure: Wire-guided localization

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Gong, doctor; Phone Number: 02034070499; Email: changgong282@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Gong Chang, doctor; Phone Number: 02034070499; Email: changgong282@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Untreated patients-combined localization; In untreated non-palpable breast cancer patients, positioning focus use wire and marker clip at 1day before operation	Procedure: Wire-guided localization and marker clip localization; Positioning guide wire and marker clip in the center of the lesion
Active Comparator: Untreated patients-single localization; In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation	Procedure: Wire-guided localization; Positioning guide wire in the center of the lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-operation rate	the proportion of patients which have a positive margin and requires reoperation	up to 3 months after first operation
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
IDFS	Time from surgery to the first occurrence of local, distant disease recurrence, or death.	2 years, 3 years, and 5 years

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SYSKY-2023-129-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No