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
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
1 other identifier
observational
798
10 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2021
CompletedFirst Posted
Study publicly available on registry
March 19, 2021
CompletedStudy Start
First participant enrolled
May 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2022
CompletedMarch 6, 2023
February 1, 2023
11 months
March 18, 2021
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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 )
Retrospective: From 01 January 2015 to 31 December 2020
Disease outcome: Time to first subsequent treatment (TFST)
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.
Retrospective: From 01 January 2015 to 31 December 2020
Disease outcome: Time to treatment failure (TTF)
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.
Retrospective: From 01 January 2015 to 31 December 2020
Disease outcome: Overall survival (OS)
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.
Retrospective: From 01 January 2015 to 31 December 2020
Secondary Outcomes (4)
Clinicopathological characteristics in patients with HER2 low BC
Retrospective: From 01 January 2015 to 31 December 2020
Concordance of HER2 rescore with historical HER2 score
Retrospective: From 01 January 2015 to 31 December 2020
Prevalence of HER2 low among unresectable and/or mBC patients identified as HER2-neg based on other IHC assays
Retrospective: From 01 January 2015 to 31 December 2020
Prevalence of HER2 low in HR-positive and HR-negative population
Retrospective: From 01 January 2015 to 31 December 2020
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patients will be eligible for study inclusion if their mBC diagnosis date is between 01 January 2015 and 31 December 2017 (dating back from 31 December 2017 but no older than 01 January 2015).
You may qualify if:
- Men or women:
- ≥ 18 years of age when consent provided for future sample and clinical data use - applicable for all countries participating in the study except Japan
- ≥ 20 years of age when consent provided for future sample and clinical data use - applicable for Japan only
- Must have a histological or cytological confirmed diagnosis of unresectable or/and mBC between 01 January 2015 and 31 December 2017
- 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
- Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status
- 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
- Must have historical HER2 fixed tissue IHC stained slides (preferably stained using Ventana 4B5 assay) in acceptable quality for accurate rescoring.
You may not qualify if:
- Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin
- Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Daiichi Sankyocollaborator
Study Sites (13)
Research Site
Pittsburgh, Pennsylvania, 15213, United States
Research Site
Melbourne, Australia
Research Site
Montreal, Quebec, H3T 1R2, Canada
Research Site
Clermont-Ferrand, 63011, France
Research Site
Erlangen, 91054, Germany
Research Site
Milan, 20141, Italy
Research Site
Chūōku, 104-8560, Japan
Research Site
Fukuoka, 811-1395, Japan
Research Site
Isehara, 259-1193, Japan
Research Site
Lisbon, 1649-035, Portugal
Research Site
Porto, 4200-319, Portugal
Research Site
Seoul, 03722, South Korea
Research Site
Manchester, M20 4BX, United Kingdom
Related Publications (1)
Viale G, Basik M, Niikura N, Tokunaga E, Brucker S, Penault-Llorca F, Hayashi N, Sohn J, Teixeira de Sousa R, Brufsky AM, O'Brien CS, Schmitt F, Higgins G, Varghese D, James GD, Moh A, Livingston A, de Giorgio-Miller V. Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatments received, and outcomes of HER2-low breast cancer. ESMO Open. 2023 Aug;8(4):101615. doi: 10.1016/j.esmoop.2023.101615. Epub 2023 Aug 8.
PMID: 37562195DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2021
First Posted
March 19, 2021
Study Start
May 28, 2021
Primary Completion
April 26, 2022
Study Completion
April 26, 2022
Last Updated
March 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 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.
- Access Criteria
- 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.
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.