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

Recruiting now · Not applicable

Conditions studied: Breast Cancer (Locally Advanced or Metastatic), Tattoo Skin Markers, Neoadjuvant Chemoimmunotherapy

In brief

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.

Key facts

Study ID

NCT07478900

Run by

All India Institute of Medical Sciences, Bhubaneswar

People needed

30

Starts

2025-09-10

Expected to finish

2028-02-09

Last updated by the study team

2026-03-18

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• AIIMS Bhubaneswar — Bhubaneswar, Odisha, India (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.