RecruitingNot applicableFemale onlyEN originalBreast cancerMetastatic / advanced

Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

Study Description This prospective cohort study evaluates the feasibility and effectiveness of pre-neoadjuvant tumor localization using skin tattooing, with or without radiopaque clips, in patients with biopsy-proven T2-T3 breast cancer and axillary lymph node metastasis. Eligible patients will undergo tumor localization in the supine position with the ipsilateral arm abducted to 90°. Palpable tumor margins will be marked with sterile tattoo ink, and deep or mobile tumors will receive additional localization with ultrasonography-guided radiopaque clips. Following localization, patients will receive standard neoadjuvant chemotherapy. Tumor response will be monitored clinically and radiologically. Post-therapy, the tattoo markings and/or clips will guide breast-conserving surgery. Primary outcomes include feasibility of breast conservation, achievement of negative margins (R0 resection), and avoidance of mastectomy, while intraoperative technical challenges will also be documented.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobiety w wieku 18-75 lat
  • Rak piersi potwierdzony badaniem histologicznym (pobraniem próbki tkanki)
  • Guz piersi średniego lub dużego rozmiaru (T2 lub T3) zakwalifikowany do chemioterapii przed operacją
  • Wyczuwalny pierwotny guz piersi, który można zlokalizować
  • Pacjentki mogące poddać się operacji oszczędzającej pierś po chemioterapii
  • Gotowość do podpisania świadomej zgody

✗ Disqualifies

  • Alergia lub uczulenie na materiały używane do znakowania guza
  • Wczesny stadium raka piersi niekwalifikujące się do chemioterapii przedoperacyjnej
  • Zapalny rak piersi
  • Duży guz (T3/T4) u pacjentek z małymi piersiami
  • Pacjentki niechętne do operacji oszczędzającej pierś
  • Rozległy rozsiew mikrozapalений w tkance piersi
  • Rak przewodowy (bez inwazji)
  • Wieloogniskowy lub rozszczepiony rak piersi

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
75 Years
Last updated (source)
March 18, 2026
Sex
Female only

Therapies / drugs in trial

Locations (1)

AIIMS Bhubaneswar

Bhubaneswar, India

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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