Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT06529302
Eligibility Criteria:
Inclusion Criteria:
* Consecutive women and men aged 18 years or older with a diagnosis of stage I-III breast cancer (any histological and receptor subtype)
* For Clinically Node negative (cN0) at presentation: any axillary staging technique including palpation is allowed. Dual tracer mapping is not required for Sentinel Lymph Node Biopsy (SLNB)
* For Clinically Node positive (cN+) at presentation: Biopsy proven confirmation is required. Staging techniques include: SLNB with dual mapping or targeted axillary dissection (Targeted Axillary Dissection, TAD: imaging-guided localization of sampled node in combination with Sentinel Lymph Node procedure with or without dual mapping) or the Marking Axillary Lymph Nodes with Iodine Seeds (MARI) procedure
* Completed neoadjuvant chemotherapy
* Residual micrometastases detected on SLNB or TAD or MARI (on frozen section or final pathology)
* Concomitant presence of Isolated Tumor Cells (ITCs) and micrometastases in other sentinel lymph nodes is allowed
* Received axillary treatment with completion axillary lymph node dissection (ALND), axillary Radiotherapy (ART), both or none
* At least 1-year follow-up (inclusion should end in May 2023)
* Had surgery at any time point until May 2023 at the latest
* Prior history of stage I-III (not stage IV) breast cancer is allowed
Exclusion Criteria:
* Did not undergo SLNB/TAD/MARI (e.g., went straight to ALND or ART)
* Presence of ITCs alone or macrometastases on the sentinel nodes (or TAD nodes or MARI node)
* Stage IV disease at presentation
* Inflammatory breast cancer at presentation
* Neoadjuvant endocrine therapy
* Micrometastases detected by One-step nucleic acid amplification (OSNA)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06529302
Study Brief:
Protocol Section:
NCT06529302