Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study.
- Who it may be relevant to
- Registry conditions: Breast Cancer (Locally Advanced or Metastatic), Tattoo Skin Markers, Neoadjuvant Chemoimmunotherapy. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study
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.
Interventions
- Procedure Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study
Eligible patients with biopsy-proven breast cancer and axillary lymph node metastasis presenting with clinical T1-T2 disease will undergo localization of the primary tumor prior to initiation of neoadjuvant chemotherapy. The procedure will be performed with the patient in the supine position and the ipsilateral arm abducted to 90°, simulating the surgical position. Clinically palpable tumor margins will be identified and marked on the overlying skin using sterile permanent tattoo ink to delineat
Primary outcome measures
- Complete excision of breast tumor with negative histopathological margins (R0 Resection) [Time frame: Tumor margins will be assessed intraoperatively by frozen section biopsy and subsequently confirmed by the final histopathological examination two weeks after the procedure.]
- Complete Pathological Excision of the Breast Tumor (R0 Resection) [Time frame: The study will be conducted over 24 months (November 2025-October 2027). Patients will be followed for wound-related complications for two weeks, with additional follow-up at one and three months to assess wound healing and patient satisfaction.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
India · 1 center
- AIIMS Bhubaneswar — Bhubaneswar
Identifiers
NCT: NCT07478900 · IEC/AIIMSBBSR/PG/2025-26/53 · IEC/AIIMSBBSR/PG/2025-26/53