Status:
COMPLETED
HER2 TREAT Study: Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable and/or Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council
Lead Sponsor:
AstraZeneca
Conditions:
Breast Neoplasms
Breast Cancer
Eligibility:
FEMALE
Brief Summary
HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negat...
Eligibility Criteria
Inclusion
- women ≥ 18 years of age at date of diagnosis
- Patients must have a histological or cytological confirmed diagnosis of Unresectable or/and mBC between 01st January 2018 and 31st December 2022.
- Patients with at least 12 months of follow-up data (from the index date) in the medical records at the participating site unless patient died.
- Patients must have been diagnosed as HER2-negative (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status.
- Patients who are diagnosed and/or progressed on at least one prior systemic anticancer therapy (e.g., ET, chemotherapy, CDK4/6i, targeted therapies other than anti- HER2, or immunotherapy) in the metastatic setting.
- Patients must have historical HER2 fixed tissue IHC stained slides in acceptable quality to allow retesting of HER2 expression only in case of the absence of accurate scoring of IHC/ISH in pathology report.
Exclusion
- Have a history of other malignancies other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin.
- Patients who are HER2 positive (with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.
Key Trial Info
Start Date :
March 5 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT06125314
Start Date
March 5 2024
End Date
September 30 2024
Last Update
September 23 2025
Active Locations (7)
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1
Research Site
Kuwait City, Kuwait
2
Research Site
Doha, Qatar
3
Research Site
Mecca, Saudi Arabia, Saudi Arabia
4
Research Site
Riyadh, Saudi Arabia