Trial Title:
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
NCT ID:
NCT06131424
Condition:
HER2-negative
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
HER2 Low, Metastatic breast cancer
HR:Hormone Receptor, IHC:mmunohistochemistry
ISH: in situ hybridization
Anticancer therapy
Prognostic and Predictive Biomarker
Formalin-fixed, paraffin-embedded (FFPE)
endocrine therapy(ET)
Subsets
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
This noninterventional, multicenter,retrospective study has been proposed to estimate the
prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes
of human epidermal growth factor receptor 2 -(HER2)low locally-advanced or metastatic
breast cancer(mBC) by accurate rescoring of archived IHC-stained formalin-fixed
paraffin-embedded (FFPE) slides for HER2 in patients previously identified as
HER2-negative from emerging markets of international regions (non-US and non-European
region) with largely unknown prevalence estimates of HER2 low mBCs. Patients with a
confirmed diagnosis of HER2-negative, locally-advanced or mBC regardless of Hormone
receptor (HR)status between 01 January 2019 and 31 December 2022 who progressed on any
systematic anticancer therapy (eg, ET, chemotherapy, CDK4/6 inhibitor, targeted therapies
other than anti-HER2, or immunotherapy) in advanced disease with availability of atleast
12 months of follow-up data (from the index date) in the medical records at the
participating site, unless patient died within the first 12 months of diagnosis of
locally-advanced or mBC will be enrolled in the study. The HR positive patients will be
considered eligible for the study if they have received ET as adjuvant therapy in the
early BC setting and progressed within 24 months. This scenario will be considered as
progression on systematic treatment in the advanced or metastatic setting.
Detailed description:
Multicenter, noninterventional, retrospective study, aimed to determine the prevalence of
HER2-low and HER2>0<1+ by rescoring of archived IHC-stained FFPE slides for HER2 in
patients previously identified as having HER2-negative locally-advanced or mBC who
progressed on any systemic anticancer therapy.The study will also describe the baseline
sociodemographic and clinicopathological characteristics, treatment patterns, clinical
outcomes and concordance between historical IHC status and rescored IHC status of
archived IHC-stained FFPE slides. The study will not have any study-specific patient
visits, procedures, or a longitudinal follow-up. All available data will be extracted
from patients' medical records. The study will consist of 2 components: rescoring of
archived IHC-stained FFPE slides and secondary data collection from patients' medical
records. Human epidermal growth factor receptor 2 IHC historical scores, HER2 rescoring
results of archived IHC-stained FFPE slides by qualified laboratory (local and/or
independent central laboratory), other biomarker testing results based on historical
testing and/or testing of archived tissue samples when available. The data on different
types of treatment received by the patients and sociodemographics and clinicopathological
characteristics will be extracted from patients' medical records from the date of
diagnosis of HER2-negative BC up to the date of data extraction.
The patients identified for the current study will be a convenience sample of all
patients in the relevant electronic health record/electronic medical record databases and
biobanks who meet the inclusion and exclusion criteria; no a priori power analysis will
be conducted. The study aims to capture approximately minimal 150 to 200 HER2-negative
mBC patients per participating country/cluster, in order to generate data on 2100 to 2700
patients overall, with the aim to identify approximately 1050 HER2-low patients (at least
600 patients in Asia cohort and 450 patients in Latin America [LATAM] cohort) for
analysis, subject to revision based on preliminary data analysis. Clinical outcomes will
be assessed as per the HER2 subsets identified after rescoring (HER2 low-IHC1+ or
IHC2+/ISH-, HER2 IHC>0<1+, HER2 null, and HER2 zero-HER2 IHC>0<1+ and HER2 null). The
study will be conducted in 8 Asian countries including Hong Kong, India, Indonesia,
Malaysia, Philippines, Thailand, Singapore, and Vietnam and 6 Latin American (LATAM)
countries including Argentina, Brazil, Chile, Dominican Republic, Mexico, and Panamá.
Regions and countries may be added based on feasibility assessment as per AstraZeneca's
standard operating procedures. A total of approximately 2100 to 2700 patients with a
confirmed diagnosis of HER2-negative, locally-advanced or mBC regardless of HR status
between 01 January 2019 and 31 December 2022 with the availability of medical records of
at least 12 months of follow-up data (from the index date), and deemed eligible as per
the study eligibility criteria will be enrolled in the study at approximately 28-58 study
sites. The study protocol and informed consent form (ICF) will be approved by local
Institutional Review Boards (IRBs)/(Institutional) Ethics Committees (IECs) before the
commencement of recruitment.
Criteria for eligibility:
Study pop:
Eligible patients from sites will be selected in a consecutive manner ie, patients with
dates closest to but on or after 01 January 2019 will be selected first.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:1. Men or women, ≥18 years of age 2. Provision of informed consent by
the patient or next of kin/legal representative (for deceased patients at study entry,
unless a waiver was granted) according to local regulations 3. Must have a histological
or cytological confirmed previous diagnosis as HER2-negative (IHC zero, 1+, 2+/ISH-)
locally-advanced or mBC between 01 January 2019 and 31 December 2022, regardless of HR
status 4. Must have progressed on any systemic anticancer therapy (eg, ET, chemotherapy,
CDK4/6 inhibitor, targeted therapies other than anti-HER2, or immunotherapy) in the
metastatic setting with the availability of at least 12 months of follow-up data (from
the index date) in the medical records at the participating site, unless patient died
within the first 12 months of diagnosis a) The HR positive patients will be considered
eligible for the study if they have received ET as adjuvant therapy in the early BC
setting and progressed within 24 months, this scenario will be considered as progression
on systematic treatment in the advanced or metastatic setting 5. Must have historical
IHC-stained FFPE tissue from locally-advanced or mBC slides for HER2 in an acceptable
quality to allow for accurate rescoring of HER2 expression - Exclusion Criteria:1. Have a
history of other malignancies, other than basal cell carcinoma of the skin and squamous
cell carcinoma of the skin until 3 years prior to diagnosis of locally-advanced or mBC 2.
Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Santo Domingo
Country:
Dominican Republic
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bengaluru
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Delhi
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hyderabad
Country:
India
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kochi
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Mumbai
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Varanasi
Country:
India
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Jakarta
Country:
Indonesia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Kaula Lumpur
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Subang Jaya
Country:
Malaysia
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ciudad de Mexico
Country:
Mexico
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Panama
Country:
Panama
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Quezon city
Country:
Philippines
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Singapore
Country:
Singapore
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bangkok
Country:
Thailand
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hanoi
Country:
Vietnam
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Ho Chi Minh
Country:
Vietnam
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Hue
Country:
Vietnam
Status:
Not yet recruiting
Start date:
April 23, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06131424
