Immune checkpoint washout for axillary lymph node staging in invasive ductal breast cancer
Detection of Lymph Node Positivity in Patients With Invasive Ductal Breast Cancer Using Immun Checkpoint Washout
This test sees if washing axillary lymph nodes for immune checkpoint markers can help find cancer spread in people with invasive ductal breast cancer who are scheduled for neoadjuvant therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Istanbul Training and Research Hospital Government |
| Drugs / interventions | ipilimumab, nivolumab |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07003009 on ClinicalTrials.gov |
What this trial studies
Patients with histopathologically confirmed invasive ductal carcinoma who are planned for neoadjuvant therapy will have washout fluid collected from axillary lymph nodes characterized as benign or suspicious on ultrasound. Washout specimens will be analyzed for immune checkpoint markers and compared with results from fine-needle aspiration or core biopsy and final pathology. The aim is to determine whether immune checkpoint washout could serve as a faster, lower-cost adjunct to ultrasound and biopsy for lymph node staging. Standard exclusions include negative FNAB of a suspected metastatic node, malignant FNAB of a presumed healthy node, pregnancy, immunodeficiency, or another primary malignancy.
Who should consider this trial
Good fit: Adults with confirmed invasive ductal carcinoma who are scheduled to receive neoadjuvant therapy and are undergoing axillary lymph node evaluation are ideal candidates.
Not a fit: Patients with discordant FNAB results as specified in the exclusions, pregnant people, those with immunodeficiency, or those with another primary cancer would be excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, this method could provide a faster and less costly way to detect axillary metastases and help guide preoperative treatment decisions.
How similar studies have performed: Washout testing is well established in thyroid cancer, but applying immune checkpoint washout to breast axillary node staging is largely novel with limited supporting data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histopathologically proven invasive ductal carcinoma * Patients who will have neoadjuvant therapy Exclusion Criteria: * The fine-needle aspiration biopsy (FNAB) result of the suspected metastatic lymph node is negative. * The FNAB result of the presumed healthy lymph node is malignant. * They refuse to participate in the study. * They have another primary malignancy. * They are pregnant. * They have a history of immunodeficiency.
Where this trial is running
Istanbul
- Istanbul Training and Research Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ufuk Oguz Idiz, Assoc. Prof. MD. PhD
- Email: ufukidiz@gmail.com
- Phone: +905062044714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.