NCT06188494Completed
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 · Last updated 18 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 405 (actual)
- First submitted
- 13 Nov 2023
- Start date
- 13 May 2024
- Primary completion date
- 16 Sept 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Childhood cancers
- NCT number
- NCT06188494
What you commit to
- Study type: Observational
- Participants enrolled: 405
- From 13 May 2024 to the primary completion date, 16 Sept 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Alexandria | Egypt | Unknown status |
| - Coordinator of this site? Confirm its status | Asyut | Egypt | Unknown status |
| - Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
| - Coordinator of this site? Confirm its status | Gharbia | Egypt | Unknown status |
| - Coordinator of this site? Confirm its status | Giza | Egypt | Unknown status |
| - Coordinator of this site? Confirm its status | Luxor | Egypt | Unknown status |
| - Coordinator of this site? Confirm its status | Sohag | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.