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:
NCT06833502
Eligibility Criteria:
Inclusion Criteria:
* Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status.
* HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines27. Triple negative will be classified as ER and PR \<10% and HER2-.
* Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.
* Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients.
* Age ≥ 18.
* Life expectancy ≥ 6 months.
* Eastern Cooperative Oncology Group performance status 0 to 2.
* Patients must be able to understand and the willingness to sign an informed consent for study procedures.
* Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria:
* Prior diagnosis of systemic metastases.
* Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.
* Contraindication towards CT IV contrast.
* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06833502
Study Brief:
Protocol Section:
NCT06833502