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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT06188494
Eligibility Criteria:
Inclusion Criteria:
1. Men or women ≥ 18 years of age,
2. Must have a histological, cytological, or radiological confirmed diagnosis of unresectable or/and mBC between 01 January 2017 and 31 December 2020, with at least 2 years of follow-up data unless patient's death is confirmed,
3. Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status,
4. Must have a report in her file with HER2 scoring with IHC/ISH or both,
5. Progressed on any systemic anti-cancer therapy (eg, ET, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting.
6. Due to the retrospective nature of the study a waiver grant of the consent will be requested from the IRB/IEC for the study participants, if waiver not granted Patient or next of kin/legal representative (for deceased patients at study entry) willing and able to provide written informed consent according to the local regulations.
Exclusion Criteria:
* Records of patients who meet any of the following criteria will be excluded:
1. History of other malignancies than mBC,
2. Historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06188494
Study Brief:
Protocol Section:
NCT06188494