Breast CancerNCT06188494
UNFOLD Study Egypt
An observational study of Breast Cancer, run by AstraZeneca at 7 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 405 participants
- Where
- 7 sitesEgypt
- Study dates
- 13 May 2024to 16 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Egypt7 sites
Research Site
Alexandria
Research Site
Asyut
Research Site
Cairo
Research Site
Gharbia
Research Site
Giza
Research Site
Luxor
Research Site
Sohag
About this study
Official title: 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
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.
Read the 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 American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) had a revised guideline for HER2 testing in breast cancer. Breast cancers were traditionally classified as HER2-pos and HER2-neg. HER2-positive BCs are those with either IHC3+ -characterized as complete, intense circumferential membrane staining in >10% of cells-, or equivocal IHC (i.e., IHC2+) -characterized as weak to moderate/complete membrane staining in >10% of cells- and ISH+. While HER2-negative BCs were considered those with one of the following results: IHC0 (No staining or incomplete, faint/barely perceptible staining in ≤10% of cells), IHC1+ (No staining or incomplete, faint/barely perceptible staining in >10% of cells), or IHC2+ and ISH-. Recently, the HER2 categorization of BC has been differentiated into 3 subgroups: those with no detectable IHC staining (referred to herein as HER2 null), those with detectable HER2 staining in less than 10% of tumor cells (referred to herein as IHC>0<1+), and those with IHC1+ or IHC2+/ISH- results (collectively referred to herein as HER2-low). Little is known about the prevalence and clinical implications of HER2-neg BC subgroups that express low levels of HER2; these cancers have traditionally not been considered as separate subgroups and consequently there has been a lack of HER2-directed treatment options for these patients.
Treatment options for mBC depend on several factors including, but not limited to, the patient's overall health and the levels of hormone receptor (HR) and HER2 in the tumor. Current SoC that is based on HER2 expression only considers BCs as being either HER2-pos or HER2-neg. For HER2-pos cancers, therapies that target HER2 combined with chemotherapy or other anti-HER2 agents can significantly improve survival. Although there are no therapies specifically for patients with HER2-low BC, preliminary evidence has demonstrated antitumor activity of T-DXd, an anti-HER2 agent, in HER2-low BCs. Hence, applying the most recent cut-off values when testing for HER2 expression is critical for maximizing treatment benefit for the highest number of patients (HER2-low \& HER2-pos).
This national, multicenter, non-interventional, secondary data collection, retrospective study aims to describe the prevalence of HER2-low BC in Egypt by accurate categorization of HER2 status in HER2 reports of patients previously determined as HER2-neg and analyzing the SoC and clinical outcomes of HER2-low patients from medical chart abstraction.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
HER2-low prevalence
HER2-low prevalence based on reviewing historical HER2 reports of HER2-neg mBC patients.
Measured: 3 Years
Secondary outcomes (9)
HER2-low Breast Cancer Patient Baseline characteristics
Baseline characteristics for patients identified as having HER2-low BC.
Measured: 3 Years
HER2 IHC Null Breast Cancer Patient Baseline Characteristics
Baseline characteristics for patients identified as having HER2 IHC Null BC.
Measured: 3 Years
The overall prevalence of HER2-low among unresectable and/or mBC patients
The overall prevalence of HER2-low among unresectable and/or mBC patients identified as HER2-neg, regardless of assays used, will also be summarized descriptively for HR-pos and HR-neg population, respectively.
Measured: 3 Years
Treatment patterns
Types of therapies for patients will be summarized descriptively for HR-pos and HR-neg population, respectively.
Measured: 3 Years
HER2-low Breast Cancer Clinical presentation for patients
clinical presentation for patients identified as having HER2-low BC.
Measured: 3 Years
HER2 IHC Null Breast Cancer clinical presentation for patients
clinical presentation for patients identified as having HER2 IHC Null BC.
Measured: 3 Years
HER2-low Breast Cancer Patients Clinical outcomes
Clinical outcomes for patients identified as having HER2-low BC.
Measured: 3 Years
HER2 IHC Null Breast Cancer Patients Clinical outcome
Clinical outcomes for patients identified as having HER2 IHC Null BC.
Measured: 3 Years
Treatment Patterns
Duration on treatment therapies for patients will be summarized descriptively for HR-pos and HR-neg population, respectively.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start13 May 2024
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188494
- Sponsor's protocol ID
- D133FR00199
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06188494
- Acronym / sponsor ID
- D133FR00199
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 May 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) had a revised guideline for HER2 testing in breast cancer. Breast cancers were traditionally classified as HER2-pos and HER2-neg. HER2-positive BCs are those with either IHC3+ -characterized as complete, intense circumferential membrane staining in >10% of cells-, or equivocal IHC (i.e., IHC2+) -characterized as weak to moderate/complete membrane staining in >10% of cells- and ISH+. While HER2-negative BCs were considered those with one of the following results: IHC0 (No staining or incomplete, faint/barely perceptible staining in ≤10% of cells), IHC1+ (No staining or incomplete, faint/barely perceptible staining in >10% of cells), or IHC2+ and ISH-. Recently, the HER2 categorization of BC has been differentiated into 3 subgroups: those with no detectable IHC staining (referred to herein as HER2 null), those with detectable HER2 staining in less than 10% of tumor cells (referred to herein as IHC>0<1+), and those with IHC1+ or IHC2+/ISH- results (collectively referred to herein as HER2-low). Little is known about the prevalence and clinical implications of HER2-neg BC subgroups that express low levels of HER2; these cancers have traditionally not been considered as separate subgroups and consequently there has been a lack of HER2-directed treatment options for these patients.
Treatment options for mBC depend on several factors including, but not limited to, the patient's overall health and the levels of hormone receptor (HR) and HER2 in the tumor. Current SoC that is based on HER2 expression only considers BCs as being either HER2-pos or HER2-neg. For HER2-pos cancers, therapies that target HER2 combined with chemotherapy or other anti-HER2 agents can significantly improve survival. Although there are no therapies specifically for patients with HER2-low BC, preliminary evidence has demonstrated antitumor activity of T-DXd, an anti-HER2 agent, in HER2-low BCs. Hence, applying the most recent cut-off values when testing for HER2 expression is critical for maximizing treatment benefit for the highest number of patients (HER2-low \& HER2-pos).
This national, multicenter, non-interventional, secondary data collection, retrospective study aims to describe the prevalence of HER2-low BC in Egypt by accurate categorization of HER2 status in HER2 reports of patients previously determined as HER2-neg and analyzing the SoC and clinical outcomes of HER2-low patients from medical chart abstraction.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Records of patients who meet any of the following criteria will be excluded:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HER2-low prevalence
Time frame: 3 Years
HER2-low prevalence based on reviewing historical HER2 reports of HER2-neg mBC patients.
9 secondary outcomes
HER2-low Breast Cancer Patient Baseline characteristics
Time frame: 3 Years
HER2 IHC Null Breast Cancer Patient Baseline Characteristics
Time frame: 3 Years
The overall prevalence of HER2-low among unresectable and/or mBC patients
Time frame: 3 Years
Treatment patterns
Time frame: 3 Years
HER2-low Breast Cancer Clinical presentation for patients
Time frame: 3 Years
HER2 IHC Null Breast Cancer clinical presentation for patients
Time frame: 3 Years
HER2-low Breast Cancer Patients Clinical outcomes
Time frame: 3 Years
HER2 IHC Null Breast Cancer Patients Clinical outcome
Time frame: 3 Years
Treatment Patterns
Time frame: 3 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- CSR Synopsis redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 7 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HER2-low prevalence (time frame: 3 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.