Status:
COMPLETED
UNFOLD Study Egypt
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
All Genders
Brief Summary
Breast cancer is a major public health concern worldwide. In Egypt, it was the most diagnosed cancer among females in 2020 with an incidence rate of 32.4%. Its age-standardized incidence and mortality...
Detailed Description
Besides its role in the prognostic assessment of breast cancer, accurate determination of HER2 status is critical for appropriate selection of eligible patients for targeted therapy. In 2018, the Amer...
Eligibility Criteria
Inclusion
- Men or women ≥ 18 years of age,
- 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,
- Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status,
- Must have a report in her file with HER2 scoring with IHC/ISH or both,
- Progressed on any systemic anti-cancer therapy (eg, ET, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting.
- 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
- Records of patients who meet any of the following criteria will be excluded:
- History of other malignancies than mBC,
- Historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.
Key Trial Info
Start Date :
May 13 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT06188494
Start Date
May 13 2024
End Date
September 16 2024
Last Update
September 18 2025
Active Locations (7)
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1
Research Site
Alexandria, Egypt
2
Research Site
Asyut, Egypt
3
Research Site
Cairo, Egypt
4
Research Site
Gharbia, Egypt