UNFOLD Study Egypt

NCT06188494 | Completed

• 1 other identifier: D133FR00199
• Study Type: observational
• Target: 405
• Locations: 1 country
• Sites: 7

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 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• HER2-low prevalence

  HER2-low prevalence based on reviewing historical HER2 reports of HER2-neg mBC patients.

  3 Years

Secondary Outcomes (9)

• HER2-low Breast Cancer Patient Baseline characteristics

  3 Years

• HER2 IHC Null Breast Cancer Patient Baseline Characteristics

  3 Years

• The overall prevalence of HER2-low among unresectable and/or mBC patients

  3 Years

• Treatment patterns

  3 Years

• HER2-low Breast Cancer Clinical presentation for patients

  3 Years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed diagnosis of HER2-negative, unresectable and/or mBC (regardless of HR status) between 01 January 2017 and 31 December 2020 who progressed on any systematic anticancer therapy (eg, ET, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy). Patients' clinical outcomes will be followed up for 2 years after the date of their diagnosis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (7)

Research Site

Alexandria, Egypt

Location

Research Site

Asyut, Egypt

Location

Research Site

Cairo, Egypt

Location

Research Site

Gharbia, Egypt

Location

Research Site

Giza, Egypt

Location

Research Site

Luxor, Egypt

Location

Research Site

Sohag, Egypt

Location

Related Links

• CSR Synopsis redacted

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: January 3, 2024
• Study Start: May 13, 2024
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

EG (7)