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

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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).

Key facts

Study ID

NCT07106112

Run by

Saint Petersburg State University, Russia

People needed

110

Starts

2025-05-15

Expected to finish

2026-12-31

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women ≥18 years.
• Morphologically confirmed breast cancer (T1-3N1M0).
• ECOG 0-1.
• Indication for neoadjuvant therapy.
• Signed informed consent.

You may not qualify if…

• No lymph node regression post-neoadjuvant therapy (persistent N1).
• Distant metastasis progression.
• Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).

Where it is running

• St. Petersburg State University — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

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