Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06188494 |
| Other study ID # |
D133FR00199 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 31, 2023 |
| Est. completion date |
November 30, 2024 |
Study information
| Verified date |
December 2023 |
| Source |
AstraZeneca |
| Contact |
AstraZeneca Clinical Study Information Center |
| Phone |
1-877-240-9479 |
| Email |
information.center[@]astrazeneca.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
