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NCT Number: NCT07478900

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

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.

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Key information

Conditions

Breast Cancer (Locally Advanced or Metastatic) Breast Diseases Breast Neoplasms Neoadjuvant Chemoimmunotherapy Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Tattoo Skin Markers

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study

Procedure

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 delineate the pretreatment tumor boundaries. In patients with deep, poorly palpable, or mobile tumors, additional localization will be achieved by placement of radiopaque clips within the tumor under ultrasonographic guidance. Following localization, patients will receive standard neoadjuvant chemotherapy according to institutional protocols. Treatment response will be monitored clinically and radiologically, and the tattoo markings and/or clips will guide surgical planning for breast-conserving surgery

Primary outcomes

  1. 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.

  2. 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.

    The study will be conducted over 24 months (November 2025-October 2027) in the Department of General Surgery. Eligible patients undergoing Breast-Conserving Surgery for Breast Cancer will be enrolled. Excised specimens will undergo Histopathological Examination to assess surgical margins. The primary outcome is the achievement of negative margins. If negative margins are obtained, the surgery will be considered successful; positive margins will require revision surgery (re-excision) and will be recorded as failure of the primary procedure. 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. Data collection will occur within the study period. Data analysis and manuscript preparation will done thereafter.

Study contacts

Contact information is provided by the study sponsor or research team.

Banothu Raju, MBBS

CONTACT

[email protected]

+917993575975

Mithilesh K Sinha, MS

CONTACT

[email protected]

+919438884252

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Official study title

Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study

Acronym: TUMS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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