NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
iRetroBC
Multicentre NIS Retrospective Study to Know the Prevalence of HER2- Low,Clinical Characteristics,Treatment Patterns,Associated Outcome in Patient With HER2-negative in Metastatic Breast Cancer Who Progressed on Systemic Anticancer Therapy
1 other identifier
observational
1,151
13 countries
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
31 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
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
November 14, 2023
CompletedStudy Start
First participant enrolled
April 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2025
CompletedSeptember 18, 2025
September 1, 2025
1.1 years
November 9, 2023
September 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of patients with IHC 1+ or IHC 2+/ISH- HER2 expression.
1\. Proportion of patients with IHC 1+ or IHC 2+/ISH- HER2 expression among previously identified HER2-negative locally-advanced or mBC patients based on rescoring of archived IHC-stained FFPE slides.
6 months from the Last subject In
Proportion of patients with HER2 ultra-low (IHC 0 (pattern 0+) with membrane staining ie, incomplete and faint/barely perceptible in ≤10% tumor cells) HER2 expression and IHC null (IHC 0 ie, absent membrane staining),
Proportion of patients with HER2 ultra-low (IHC 0 (pattern 0+) with membrane staining ie, incomplete and faint/barely perceptible in ≤10% tumor cells) HER2 expression and IHC null (IHC 0 ie, absent membrane staining), expanded biomarker association with HER2-low patient characteristics, change in HER2 and HR expressions between diagnosis and treatment, concordance of HER2 IHC scores between manual rescoring and digital scoring.
6 months from the Last subject In
Secondary Outcomes (4)
Sociodemographic (age, gender, smoking status, country, ethnicity, site type [community hospital, academic hospital, biobank, research institute], family history of BC) and clinical pathological characteristics
6 months from the Last subject In
Proportions of patients in the overall study population and each study subset receiving the following treatments for early-stage BC (if available), locally-advanced or mBC
6 months from the Last subject In
Clinical outcomes
6 months from the Last subject In
Concordance between rescoring IHC status as HER2-low by central laboratory and/or local laboratory
6 months fromthe last subject In
Other Outcomes (1)
Summary of the following biomarkers using available historical next generation sequencing (NGS) or IHC results
6 months from the Last subject In
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Rosario, Argentina
Research Site
São Paulo, Brazil
Research Site
Santo Domingo, Dominican Republic
Research Site
Hong Kong, Hong Kong
Research Site
Bengaluru, Karnataka, 560017, India
Research Site
Kochi, Kerala, 682041, India
Research Site
Mumbai, Maharashtra, 400012, India
Research Site
Bhubaneshwar, Odisha, 751003, India
Research Site
Mohali, Punjab, 160055, India
Research Site
Hyderabad, Telangana, 500034, India
Research Site
Varanasi, Uttar Pradesh, 221005, India
Research Site
Delhi, 110005, India
Research Site
Delhi, 110029, India
Research Site
Delhi, 110085, India
Research Site
Jakarta, Indonesia
Research Site
Kaula Lumpur, 47500, Malaysia
Research Site
Subang Jaya, 47500, Malaysia
Research Site
Subang Jaya, 59100, Malaysia
Research Site
Mexico City, Mexico
Research Site
Panama City, Panama
Research Site
Quezon City, 1112, Philippines
Research Site
Singapore, 168583, Singapore
Research Site
Singapore, 229899, Singapore
Research Site
Singapore, 258499, Singapore
Research Site
Singapore, 308433, Singapore
Research Site
Bangkok, 10330, Thailand
Research Site
Bangkok, 10400, Thailand
Research Site
Bangkok, 10700, Thailand
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Huế, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2023
First Posted
November 14, 2023
Study Start
April 23, 2024
Primary Completion
May 19, 2025
Study Completion
May 19, 2025
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.