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

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 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.

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 breast cancer by core-needle biopsy, received neoadjuvant treatment and the lesion becomes non-palpable before enrollment.

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 breast lesion

  • marker clip localization

    Procedure/Surgery

    Positioning marker clip in the center of the breast lesion

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: patients after neoadjuvant therapy-combined localizationExperimental treatment 1 intervention
Group B: patients after neoadjuvant therapy-single localizationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Marginal positive rate

Proportion of patients with positive margin (intraoperative freezing and postoperative pathological margin tissue showing cancer)

Time frame
up to 3 months

Secondary outcomes

1

Re-operation rate.

the proportion of patients which have a positive margin and requires a re-operation

Time frame
up to 3 months
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
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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