Skin tattoo marks (and optional clips) to guide breast-conserving surgery before chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective cohort study enrolls patients with biopsy-proven T2–T3 palpable breast tumors, places sterile tattoo ink marks around tumor margins with the patient supine and the ipsilateral arm abducted to 90°, and adds ultrasound-guided radiopaque clips for deep or mobile lesions. Patients then receive standard neoadjuvant chemotherapy while tumor response is followed clinically and with imaging. After systemic therapy, the skin tattoos and/or clips are used to guide breast-conserving surgery and intraoperative challenges are recorded. Primary outcomes include rate of successful breast conservation, achievement of negative (R0) margins, and avoidance of mastectomy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Female patients aged 18-75 years

Histologically confirmed Breast Cancer on biopsy

Patients with T2 or T3 breast tumors planned for Neoadjuvant Chemotherapy

Presence of a clinically palpable primary breast tumor suitable for localization

Patients who are candidates for Breast-Conserving Surgery following neoadjuvant therapy

Ability and willingness to provide written informed consent

Exclusion Criteria:

Known allergy or hypersensitivity to tattooing materials used for tumor localization

Early-stage Breast Cancer not requiring Neoadjuvant Chemotherapy

Diagnosis of Inflammatory Breast Cancer

T3 tumors in patients with small breast size or T4 breast cancer

Patients unwilling to undergo Breast-Conserving Surgery

Diffuse microcalcifications of the breast parenchyma on Mammography

Ductal Carcinoma In Situ

Male Breast Cancer

Multicentric or multifocal breast cancers

Tumor location that precludes breast-conserving surgery

Recurrent Breast Cancer

Where it's running

• AIIMS Bhubaneswar
  Bhubaneswar, Odisha, India Recruiting

Study contacts

• Study coordinator: Mithilesh K Sinha, MS
• Email: surg_mithilesh@aiimsbhubaneswar.edu.in
• Phone: +919438884252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.