NCT05797454

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

February 26, 2023

Last Update Submit

July 1, 2024

Conditions

Breast CancerBreast-conserving Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Re-operation rate

    up to 3 months after first operation

  • The proportion of breast-conserving surgery

    up to 3 months after first operation

  • IDFS

    2 years, 3 years, and 5 years

Study Arms (2)

Untreated patients-combined localization

EXPERIMENTAL

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

Untreated patients-single localization

ACTIVE COMPARATOR

In untreated non-palpable breast cancer patients, positioning focus use wire at 1day before operation

Procedure: Wire-guided localization

Interventions

Wire-guided localization and marker clip localizationPROCEDURE

Positioning guide wire and marker clip in the center of the lesion

Untreated patients-combined localization
Wire-guided localizationPROCEDURE

Positioning guide wire in the center of the lesion

Untreated patients-single localization

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female patients, age≥18 year
  • A score of ≥ 2 on the Eastern Cooperative Oncology Group scale
  • 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
  • Patients are willing to undergo breast conserving surgery and have no contraindications to breast conserving surgery.

You may not qualify if:

  • Inflammatory breast cancer or Paget's disease
  • Breast deformities and other conditions that impact breast conservation success rate
  • 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
  • Pregnancy or lactation
  • Patients with hookwire, radioactive 125I seed or other localization techniques in the breast cancer lesions before enrollment
  • Patients with stage IV diseases or unresectable lesions in either breast
  • Patients combined with other diseases that may affect survival
  • Patients with multicentric breast cancer lesions or lesions \> 5 cm in diameter on imaging examinations
  • Patients who have previously undergone radical mastectomy for ipsilateral breast cancer or chest wall radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Chang Gong, doctor

CONTACT

02034070499changgong282@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 26, 2023

First Posted

April 4, 2023

Study Start

February 17, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)