Clinical trial · Observational
UNFOLD Study Egypt
A Multicenter, Observational, Secondary Data Collection, Retrospective, National Study to Assess the Prevalence of HER2-low Breast Cancer Among Patients Previously Diagnosed With Unresectable and/or Metastatic HER2-Negative Breast Cancer in Egypt - UNFOLD
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 rates were 48.7 and 20.4 per 100,000 population, respectively. The status quo of HER2 testing in Egypt is that all breast cancer cases are tested for HER2 protein expression on the surface of tumor cells by immunohistochemistry (IHC), and only those with score 2 (equivocal) and selected cases of score 3 are subjected for further analysis using in-situ hybridization technique (ISH) to detect HER2 gene amplification in tumor nuclei.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- HER2-low prevalence
- timeFrame
- 3 Years
- description
- HER2-low prevalence based on reviewing historical HER2 reports of HER2-neg mBC patients.
Secondary outcomes (9)
- measure
- HER2-low Breast Cancer Patient Baseline characteristics
- timeFrame
- 3 Years
- description
- Baseline characteristics for patients identified as having HER2-low BC.
- measure
- HER2 IHC Null Breast Cancer Patient Baseline Characteristics
- timeFrame
- 3 Years
- description
- Baseline characteristics for patients identified as having HER2 IHC Null BC.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available