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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04807595




Registration number
NCT04807595
Ethics application status
Date submitted
18/03/2021
Date registered
19/03/2021

Titles & IDs
Public title
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status
Scientific title
A Multicenter Study to Estimate the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2-low Status - the RetroBC-HER2L Study
Secondary ID [1] 0 0
D9673R00004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - None (Observational study)

Retrospective cohort - Patients with confirmed diagnosis of HER2-neg, unresectable and/or mBC regardless of hormone status dating back from 31 December 2017 - but no older than 01 January 2015 - who progressed on any systematic anti-cancer therapy will be involved in this study.


Other interventions: None (Observational study)
The data source for this project will be HER2 IHC historical scores, local lab rescoring of historical HER2 fixed tissue slides, independent central retesting or local lab retesting (under special occasions) of HER2 IHC status for enrolled patients who have available tissue, other biomarker testing results based on historical testing and/or testing of archived tissue samples when available, and curated patient-level data. Real-world data sources include electronic health records/electronic medical records (EHR/EMR) and biobank registries. Data from EHR/EMR sources will be curated. Biobank tissue for enrolled patients who have multiple samples available will be selected consecutively when possible and will start with the latest available samples then move backward in time.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence/Incidence of HER2 low among HER2-neg mBC patients, based on rescoring of historical HER2 fixed tissue IHC stained slides by Ventana 4B5 assay
Timepoint [1] 0 0
Retrospective: From 01 January 2015 to 31 December 2020
Primary outcome [2] 0 0
Disease outcome: Time to first subsequent treatment (TFST)
Timepoint [2] 0 0
Retrospective: From 01 January 2015 to 31 December 2020
Primary outcome [3] 0 0
Disease outcome: Time to treatment failure (TTF)
Timepoint [3] 0 0
Retrospective: From 01 January 2015 to 31 December 2020
Primary outcome [4] 0 0
Disease outcome: Overall survival (OS)
Timepoint [4] 0 0
Retrospective: From 01 January 2015 to 31 December 2020
Secondary outcome [1] 0 0
Clinicopathological characteristics in patients with HER2 low BC
Timepoint [1] 0 0
Retrospective: From 01 January 2015 to 31 December 2020
Secondary outcome [2] 0 0
Concordance of HER2 rescore with historical HER2 score
Timepoint [2] 0 0
Retrospective: From 01 January 2015 to 31 December 2020
Secondary outcome [3] 0 0
Prevalence of HER2 low among unresectable and/or mBC patients identified as HER2-neg based on other IHC assays
Timepoint [3] 0 0
Retrospective: From 01 January 2015 to 31 December 2020
Secondary outcome [4] 0 0
Prevalence of HER2 low in HR-positive and HR-negative population
Timepoint [4] 0 0
Retrospective: From 01 January 2015 to 31 December 2020

Eligibility
Key inclusion criteria
1. Men or women:

1. = 18 years of age when consent provided for future sample and clinical data use - applicable for all countries participating in the study except Japan
2. = 20 years of age when consent provided for future sample and clinical data use - applicable for Japan only
2. Must have a histological or cytological confirmed diagnosis of unresectable or/and mBC between 01 January 2015 and 31 December 2017
3. Must have provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use. If the patient is deceased, a waiver may be accepted
4. Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status
5. Progressed on any systemic anti-cancer therapy (eg, endocrine therapy, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting
6. Must have historical HER2 fixed tissue IHC stained slides (preferably stained using Ventana 4B5 assay) in acceptable quality for accurate rescoring.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin
2. Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2022
Sample size
Target
Accrual to date
Final
798
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania
Country [2] 0 0
Canada
State/province [2] 0 0
Quebec
Country [3] 0 0
France
State/province [3] 0 0
Clermont-Ferrand
Country [4] 0 0
Germany
State/province [4] 0 0
Erlangen
Country [5] 0 0
Italy
State/province [5] 0 0
Milano
Country [6] 0 0
Japan
State/province [6] 0 0
Chuo-ku
Country [7] 0 0
Japan
State/province [7] 0 0
Fukuoka
Country [8] 0 0
Japan
State/province [8] 0 0
Isehara
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Seoul
Country [10] 0 0
Portugal
State/province [10] 0 0
Lisbon
Country [11] 0 0
Portugal
State/province [11] 0 0
Porto
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04807595