Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04807595
Registration number
NCT04807595
Ethics application status
Date submitted
18/03/2021
Date registered
19/03/2021
Date last updated
6/03/2023
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
Query!
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
Query!
Secondary ID [1]
0
0
D9673R00004
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Breast
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
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
Query!
Assessment method [1]
0
0
To describe the overall prevalence and disease burden of HER2 low (IHC 1+, 2+/ISH-) among unresectable and/or mBC patients identified as HER2-neg, based on rescoring of historical HER2 fixed tissue IHC stained slides by Ventana 4B5 assay. The prevalence of HER2 low (IHC 1+, 2+/ISH-) at unresectable/metastatic BC diagnosis, determined based on rescoring of historical HER2 IHC slides locally, among patients confirmed to be HER2-neg (HER2 IHC zero and HER2 IHC 1+ and 2+/ISH-) by rescoring of historical HER2 IHC slides, will be calculated by the following, based on the re-established HER2 status determined for each patient:
Prevalence of HER2 low = (Number of patients with HER2 low)/(Total number of HER2 negative patients )
Query!
Timepoint [1]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
Primary outcome [2]
0
0
Disease outcome: Time to first subsequent treatment (TFST)
Query!
Assessment method [2]
0
0
To compare TFST between HER2 low BC patients and the HER2 IHC zero patient population. TFST is defined as the length of time from the initiation of treatment to the initiation of the patient's next systemic treatment.
Query!
Timepoint [2]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
Primary outcome [3]
0
0
Disease outcome: Time to treatment failure (TTF)
Query!
Assessment method [3]
0
0
To compare TTF between HER2 low BC patients and the HER2 IHC zero patient population. TTF is defined as the length of time from initiation of treatment to premature discontinuation.
Query!
Timepoint [3]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
Primary outcome [4]
0
0
Disease outcome: Overall survival (OS)
Query!
Assessment method [4]
0
0
To compare OS between HER2 low BC patients and the HER2 IHC zero patient population. OS is defined as the length of time from the initiation of treatment that patients are still alive.
Query!
Timepoint [4]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
Secondary outcome [1]
0
0
Clinicopathological characteristics in patients with HER2 low BC
Query!
Assessment method [1]
0
0
HER2 low disease will be assessed using descriptive statistics of histopathological and clinicopathological characteristics. A comparison will be made with the HER2 IHC zero patient population.
Query!
Timepoint [1]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
Secondary outcome [2]
0
0
Concordance of HER2 rescore with historical HER2 score
Query!
Assessment method [2]
0
0
The concordance between historical HER2 IHC scores and local lab rescoring in the HER2-neg region (IHC score zero, 1+, and 2+) will be characterized.
The concordance between historical scoringHER2 IHC scores and independent central retesting of HER2 IHC status in the HER2-neg region will be assessed using Cohen's Kappa statistics to assess agreement beyond chance alone. By convention, Kappa equal or greater than 0.8 is often considered almost perfect agreement, Kappa between 0.8 and 0.6 is considered substantial agreement.
Query!
Timepoint [2]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
Secondary outcome [3]
0
0
Prevalence of HER2 low among unresectable and/or mBC patients identified as HER2-neg based on other IHC assays
Query!
Assessment method [3]
0
0
To describe HER2 low prevalence among unresectable and/or mBC patients identified as HER2-neg based on other IHC assays, compared with Ventana 4B5 assay.
Query!
Timepoint [3]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
Secondary outcome [4]
0
0
Prevalence of HER2 low in HR-positive and HR-negative population
Query!
Assessment method [4]
0
0
The overall prevalence of HER2 low among unresectable and/or mBC patients identified as HER2-neg, regardless of assays used, will be summarized descriptively for HR-positive and HR-negative population, respectively.
Query!
Timepoint [4]
0
0
Retrospective: From 01 January 2015 to 31 December 2020
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
130
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Retrospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/05/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/04/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
798
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Research Site - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
- Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Pennsylvania
Query!
Country [2]
0
0
Canada
Query!
State/province [2]
0
0
Quebec
Query!
Country [3]
0
0
France
Query!
State/province [3]
0
0
Clermont-Ferrand
Query!
Country [4]
0
0
Germany
Query!
State/province [4]
0
0
Erlangen
Query!
Country [5]
0
0
Italy
Query!
State/province [5]
0
0
Milano
Query!
Country [6]
0
0
Japan
Query!
State/province [6]
0
0
Chuo-ku
Query!
Country [7]
0
0
Japan
Query!
State/province [7]
0
0
Fukuoka
Query!
Country [8]
0
0
Japan
Query!
State/province [8]
0
0
Isehara
Query!
Country [9]
0
0
Korea, Republic of
Query!
State/province [9]
0
0
Seoul
Query!
Country [10]
0
0
Portugal
Query!
State/province [10]
0
0
Lisbon
Query!
Country [11]
0
0
Portugal
Query!
State/province [11]
0
0
Porto
Query!
Country [12]
0
0
United Kingdom
Query!
State/province [12]
0
0
Manchester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Daiichi Sankyo
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical
records from metastatic breast cancer (mBC) patients previously identified as human epidermal
growth factor receptor 2 negative (HER2-neg), regardless of hormone status.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04807595
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04807595
Download to PDF