Clinical trial NCT04807595: 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Metastatic breast cancer
Retrospective study
Epidemiology study
Human epidermal growth factor receptor 2 negative
Human epidermal growth factor receptor 2 low
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2021-03-19
Enrollment: 798
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Detailed description: This is a worldwide, multicenter, non-interventional, retrospective study. The study will consist of 2 components. The first component involves local lab rescoring of qualified historical HER2 fixed tissue immunohistochemistry (IHC) stained slides (preferably using Ventana 4B5 assay) at sites (post-training) for mBC patients previously identified as HER2-neg, and independent central retesting of HER2 status using Ventana 4B5 assay for any enrolled patients with available archived tissue samples at designated central laboratories. Local lab rescoring and independent central retesting/local lab retesting will be conducted blinded of historical HER2 IHC scores.

The second component involves linking the rescored IHC status to the patient medical record either through registry databases or patient chart review. Such information will be used to describe the patient demographics, histopathological features, clinical presentation, and treatment patterns following mBC diagnosis, and clinical outcomes in real-world settings for all patients with HER2 scores of 0, \>0 and \< 1+, and 1+2+/ISH- (HER2 low). The clinicopathological and other relevant BC biomarker information will also be examined based on historical biomarker testing results and/or new testing conducted as part of this study.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: 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
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
measure: Disease outcome: Time to first subsequent treatment (TFST)
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
measure: Disease outcome: Time to treatment failure (TTF)
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
measure: Disease outcome: Overall survival (OS)
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
Secondary outcomes:
measure: Clinicopathological characteristics in patients with HER2 low BC
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
measure: Concordance of HER2 rescore with historical HER2 score
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
measure: Prevalence of HER2 low among unresectable and/or mBC patients identified as HER2-neg based on other IHC assays
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
measure: Prevalence of HER2 low in HR-positive and HR-negative population
timeFrame: Retrospective: From 01 January 2015 to 31 December 2020
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Melbourne
country: Australia
facility: Research Site
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Clermont-Ferrand
country: France
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Isehara
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Lisbon
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
References: