Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer (NCT07478900) | Clinical Trial Compass
RecruitingNot Applicable
Tumor Margin Skin Tattooing Before Neo-adjuvant Chemotherapy in Patients With Breast Cancer
India30 participantsStarted 2025-09-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete excision of breast tumor with negative histopathological margins (R0 Resection)
Timeframe: 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)
Timeframe: 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.
Trial details
NCT IDNCT07478900
SponsorAll India Institute of Medical Sciences, Bhubaneswar