Overview

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.

Eligibility

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