Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSaint Petersburg State University, Russia

About this trial

This single-center, randomized study aims to compare the intraoperative detection rates of axillary lymph nodes marked with carbon suspension versus metallic markers in breast cancer patients (T1-3N1M0) before neoadjuvant therapy. Primary endpoint: frequency of marked lymph node identification during surgery. Secondary endpoints: time from marking to surgery and quality of life (EORTC QLQ-BR23).

Eligibility criteria

Qualifiers

Women ≥18 years.

Morphologically confirmed breast cancer (T1-3N1M0).

ECOG 0-1.

Indication for neoadjuvant therapy.

Disqualifiers

No lymph node regression post-neoadjuvant therapy (persistent N1).

Distant metastasis progression.

Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).

Trial design

Treatments tested in this trial

  • Ultrasound-guided carbon suspension (Black Eye) injection
  • Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement

Treatment groups

110 Participants
are divided into 2 treatment groups