Breast Cancer (Locally Advanced or Metastatic)TUMSNCT07478900
Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer
A study testing Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study in people with Breast Cancer (Locally Advanced or Metastatic) and Tattoo Skin Markers, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic), Tattoo Skin Markers, Neoadjuvant Chemoimmunotherapy
- What is being tested?
- Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- 10 Sep 2025to 9 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Ductal Carcinoma In Situ
- Male Breast Cancer
- Multicentric or multifocal breast cancers
- Tumor location that precludes breast-conserving surgery
- Recurrent Breast Cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
AIIMS Bhubaneswar
Bhubaneswar, Odisha, 751019
Mithilesh K Sinha, MS, +919438884252, surg_mithilesh@aiimsbhubaneswar.edu.in
Banothu Raju, MBBS, +917993575975, banothu905@gmail.com
About this study
Official title: Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study
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.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Tattoo Skin Markers, Neoadjuvant Chemoimmunotherapy
- Being tested
- Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort studyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer | Experimental | Patients with breast cancer and axillary lymph node metastasis presenting with T1 or T2 stage disease will undergo localization of the primary tumor site using skin tattooing performed in the supine position with the arms abducted at a right angle. In cases of deep-seated or highly mobile tumors, additional localization will be achieved by placement of radiopaque clips under ultrasonographic guidance.
Following tumor localization, patients will receive neoadjuvant chemotherapy, and treatment response will be systematically monitored. The feasibility of breast-conserving surgery in this cohort will be evaluated, and any technical challenges encountered during the procedure will be documented. The primary outcome measures will include achievement of negative surgical margins and avoidance of mastectomy. Receives: Procedure: Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete excision of breast tumor with negative histopathological margins (R0 Resection)
Measured: 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) 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start10 Sep 2025
- Primary completion9 Sep 2027 (estimated)
- Study completion9 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mithilesh Kumar sinha, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478900
- Sponsor's protocol ID
- IEC/AIIMSBBSR/PG/2025-26/53
- Other IDs
- IEC/AIIMSBBSR/PG/2025-26/53
- Acronym
- TUMS
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07478900
- Acronym / sponsor ID
- TUMS / IEC/AIIMSBBSR/PG/2025-26/53
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Tattoo Skin Markers, Neoadjuvant Chemoimmunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 9 Sep 2027 (estimated)
- Study completion
- 9 Feb 2028 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer | Experimental | Procedure: Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort studyPatients with breast cancer and axillary lymph node metastasis presenting with T1 or T2 stage disease will undergo localization of the primary tumor site using skin tattooing performed in the supine position with the arms abducted at a right angle. In cases of deep-seated or highly mobile tumors, additional localization will be achieved by placement of radiopaque clips under ultrasonographic guidance. Following tumor localization, patients will receive neoadjuvant chemotherapy, and treatment response will be systematically monitored. The feasibility of breast-conserving surgery in this cohort will be evaluated, and any technical challenges encountered during the procedure will be documented. The primary outcome measures will include achievement of negative surgical margins and avoidance of mastectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort studyEligible 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 | Procedure or surgery | tumor margin skin tattooing before neo-adjuvant chemotherapy in patients with breast cancer |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Tattooing of Tumor Margins Prior to Neoadjuvant Chemotherapy in Breast Cancer Patients: Prospective cohort study in people with Breast Cancer (Locally Advanced or Metastatic) and Tattoo Skin Markers, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mithilesh K Sinha, MS (+919438884252, surg_mithilesh@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.