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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wire-guided localization and marker clip localization

    Procedure/Surgery

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

  • Wire-guided localization

    Procedure/Surgery

    Positioning guide wire in the center of the lesion

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: Untreated patients-combined localizationExperimental treatment 1 intervention
Group B: Untreated patients-single localizationActive comparator 1 intervention

Trial outcomes

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.

Time frame
up to 3 months

Secondary outcomes

1

Re-operation rate

the proportion of patients which have a positive margin and requires reoperation

Time frame
up to 3 months after first operation
2

The proportion of breast-conserving surgery

It refers to the proportion of patients who have successfully undergone breast-conserving surgery.

Time frame
up to 3 months after first operation
3

IDFS

Time from surgery to the first occurrence of local, distant disease recurrence, or death.

Time frame
2 years, 3 years, and 5 years

Other outcomes

Sponsors and contacts

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