Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06131424
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2023-11-09
Brief Title:
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Multicentre NIS Retrospective Study to Know the Prevalence of HER2- LowClinical CharacteristicsTreatment PatternsAssociated Outcome in Patient With HER2-negative in Metastatic Breast Cancer Who Progressed on Systemic Anticancer Therapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iRetroBC
Brief Summary:
This noninterventional multicenterretrospective study has been proposed to estimate the prevalence clinicopathological characteristicstreatment patterns and clinical outcomes of human epidermal growth factor receptor 2 -HER2low locally-advanced or metastatic breast cancermBC 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 HRstatus between 01 January 2019 and 31 December 2022 who progressed on any systematic anticancer therapy eg ET chemotherapy CDK46 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 HER201 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 therapyThe 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 andor independent central laboratory other biomarker testing results based on historical testing andor 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 recordelectronic 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 countrycluster 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 IHC2ISH- HER2 IHC01 HER2 null and HER2 zero-HER2 IHC01 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 AstraZenecas 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 IRBsInstitutional Ethics Committees IECs before the commencement of recruitment
The patients identified for the current study will be a convenience sample of all patients in the relevant electronic health recordelectronic 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 countrycluster 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 IHC2ISH- HER2 IHC01 HER2 null and HER2 zero-HER2 IHC01 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 AstraZenecas 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 IRBsInstitutional Ethics Committees IECs before the commencement of recruitment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None