Breast Cancer (Locally Advanced or Metastatic), Neoadjuvant Chemoimmunotherapy, Tattoo Skin Markers
Conditions
Brief summary
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
PROCEDURESkin 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 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
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete excision of breast tumor with negative histopathological margins (R0 Resection) | 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) | 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. |
Countries
India
Contacts
CONTACTMithilesh K Sinha, MS
CONTACTBanothu Raju, MBBS
Outcome results
None listed