Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000216819
Ethics application status
Approved
Date submitted
17/12/2020
Date registered
3/03/2021
Date last updated
3/03/2021
Date data sharing statement initially provided
3/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
ARORA: Advanced Hormone Receptor Positive Breast Cancer Registry in Australia
Scientific title
A registry to prospectively describe real-world clinicopathologic presentation and treatment selection in patients with advanced HR+, HER2- breast cancer in Australia
Secondary ID [1] 303021 0
nil known
Universal Trial Number (UTN)
Trial acronym
ARORA
Linked study record
no

Health condition
Health condition(s) or problem(s) studied:
Breast cancer

HR positive, HER2 negative breast cancer 320088 0
Advanced Breast Cancer 320567 0
Condition category
Condition code
Cancer 318421 318421 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2.5
Target follow-up type
Years
Description of intervention(s) / exposure
To prospectively describe real-world clinicopathologic presentation and treatment selection in patients with newly or recently diagnosed HR+ve, HER2-ve Advanced Breast Cancer in Australia of approximately 300 patients from 10-15 sites. Recruitment is expected to take place over a 3 year period. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
There is no active participation of patients required as data will be collected from medical records. Information collected would include details about the presentation and course of disease, the type and sequence of therapies and the outcomes for each patient. The data would be collected retrospectively from January 2020 onward and prospectively for new patients and data.
Intervention code [1] 319311 0
Not applicable
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326014 0
To describe real-world clinicopathologic presentation of patients with newly or recently diagnosed HR+, HER2- ABC in Australia
Timepoint [1] 326014 0
Patient data will be examined every 3 months in medical records. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Primary outcome [2] 326709 0
To describe treatment selection in patients with newly or recently diagnosed HR+, HER2- ABC in Australia
Timepoint [2] 326709 0
Patient data will be examined every 3 months in medical records. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [1] 389862 0
To assess disease free interval (DFI) for the subset of patients with relapsed ABC, defined as time from diagnosis of primary breast cancer to diagnosis of recurrence, this will be determined by results of tests ordered and reported in medical notes by treating Doctors.
Timepoint [1] 389862 0
collect data from patient records every 3 months The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [2] 389863 0
To describe treatment sequencing in the advanced setting in 1st line therapy using data from medical records
Timepoint [2] 389863 0
Collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [3] 389864 0
To estimate the average duration of each line of therapy in the 1st line treatment setting..
Timepoint [3] 389864 0
collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [4] 389865 0
To determine progression free survival, as defined by patients who are still alive and progression free, in the 1st line treatment setting.
Timepoint [4] 389865 0
Collect data from patient medical records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [5] 389866 0
To assess overall survival for patients treated in routine practice as per the medical records
Timepoint [5] 389866 0
collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [6] 389867 0
To assess time to chemotherapy use in the metastatic setting as shown in medical records
Timepoint [6] 389867 0
collect data from patient records every 3 months, The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [7] 389868 0
To determine frequency of tumour or circulating tumour DNA testing for presence of potentially actionable mutations, e.g. ESR1, PIK3CA, and incidence of these mutations. This will be ascertained by examining pathology records in the medical history.
Timepoint [7] 389868 0
collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [8] 389869 0
To understand rationale for clinicians switching to a particular line of therapy or continuing therapy beyond disease progression as per the medical records
Timepoint [8] 389869 0
collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [9] 391335 0
To estimate the average duration of each line of therapy in the 2nd line treatment setting.
Timepoint [9] 391335 0
collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [10] 391336 0
To estimate the average duration of each line of therapy in the 3rd line treatment setting.
Timepoint [10] 391336 0
collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [11] 391337 0
To determine progression free survival, as defined by patients who are still alive and progression free, in the 2nd line treatment setting.
Timepoint [11] 391337 0
Collect data from patient medical records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [12] 391338 0
To determine progression free survival, as defined by patients who are still alive and progression free, in the 3rd line treatment setting.
Timepoint [12] 391338 0
Collect data from patient medical records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [13] 391339 0
To describe treatment sequencing in the advanced setting in 2nd line therapy using data from medical records.
Timepoint [13] 391339 0
Collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.
Secondary outcome [14] 391340 0
To describe treatment sequencing in the advanced setting in 3rd line therapy using data from medical records.
Timepoint [14] 391340 0
Collect data from patient records every 3 months. The entire study duration is 4 years, with an estimated median patient follow up of 2.5 years.

Eligibility
Key inclusion criteria
1.Patients aged 18, of any gender and ECOG performance status diagnosed with advanced HR+, HER2- breast cancer (either de novo metastatic or relapsed), after 1st January 2020
2.Histological or cytological confirmation of HR+, HER2- breast cancer from either primary archival tissue or from biopsy material obtained from a metastatic site
a) Hormone receptor positivity is defined as greater than 1% of oestrogen receptor expression and/or greater than 1% of progesterone receptor expression via immunohistochemistry (IHC) analysis
b) HER2 negativity by local laboratory assessment is defined as:
- In situ hybridisation (ISH) non-amplification (ratio of HER2 to CEP 17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell) OR
- IHC 0 or IHC 1+ (as per ASCO 2018 HER2 pathology classification guidelines)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient's under 18 who have either HR-ve or HER2 +ve breast cancer
Patient's who have non metastatic breast cancer

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Kaplan-Meier survival curves will be defined from survival data and constructed using SAS® software (SAS Institute Inc., Cary, NC, USA) to compare clinical outcomes across different subgroups. The stratified log rank test will be used to compare survival curves between different groups of participants. Comparison of specific variables will be performed using the Chi square method. P-values of <0.05 will be considered statistically significant. Due to the non-randomised nature of such comparisons, propensity score techniques will be used to balance comparison groups according to baseline factors.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/03/2021
Actual
Date of last participant enrolment
Anticipated
11/03/2024
Actual
Date of last data collection
Anticipated
10/03/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 18211 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [2] 18212 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 18213 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 18214 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 18215 0
Mater Sydney - North Sydney
Recruitment hospital [6] 18216 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [7] 18217 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [8] 18218 0
Western Hospital - Footscray - Footscray
Recruitment hospital [9] 18219 0
Northern Cancer Institute - Frenchs Forest - Frenchs Forest
Recruitment postcode(s) [1] 32275 0
2060 - North Sydney
Recruitment postcode(s) [2] 32279 0
2086 - Frenchs Forest
Recruitment postcode(s) [3] 32272 0
3000 - Melbourne
Recruitment postcode(s) [4] 32278 0
3011 - Footscray
Recruitment postcode(s) [5] 32274 0
3084 - Heidelberg
Recruitment postcode(s) [6] 32271 0
3128 - Box Hill
Recruitment postcode(s) [7] 32277 0
3350 - Ballarat Central
Recruitment postcode(s) [8] 32276 0
4029 - Herston
Recruitment postcode(s) [9] 32273 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 307432 0
Commercial sector/Industry
Name [1] 307432 0
Novartos Pharmaceuticals Australia Pty Ltd
Country [1] 307432 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical research (WEHI)
Address
1G Royal Parade
Parkville VIC, 3052
Country
Australia
Secondary sponsor category [1] 308104 0
None
Name [1] 308104 0
Address [1] 308104 0
Country [1] 308104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307513 0
Melbourne Health HREC
Ethics committee address [1] 307513 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 307513 0
Australia
Date submitted for ethics approval [1] 307513 0
25/08/2020
Approval date [1] 307513 0
21/10/2020
Ethics approval number [1] 307513 0

Summary
Brief summary
This is a multi-centre prospective cohort study to collect data related to management of Hormone Receptor positive, HER2 negative advanced breast cancer in a real-world patient population.
Who is it for?
You may be elgible for this study if you are aged 18 years or older, of any gender and you have been diagnosed with metastatic, or inoperable histologically confirmed HR+, HER2- breast cancer (either metastatic at diagnosis or relapsed), after 1st January 2020.
Study details
All enrolled participants will contribute health data to the development of the registry. Participants will not have to attend additional appointments or undergo additional blood tests or scans outside of their routine treatment. Information collected from participants will include duration of therapy, the rationale for any change in treatment and uptake of targeted therapies or immunotherapy. This study will also collect data on any treatment received in the (neo) adjuvant setting, including chemotherapy and endocrine therapy as this does impact subsequent treatment decisions and treatment order in the metastatic setting.

It is hoped this research will contribute important information about all patients with HR+, HER2- advanced breast cancer and help to inform future treatment decision-making for clinicians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107506 0
Dr Sheau Wen Lok
Address 107506 0
Walter and Eliza Hall Institute 1G Royal Parade Parkville VIC 3052
Country 107506 0
Australia
Phone 107506 0
+61 3 9345 2555
Fax 107506 0
Email 107506 0
SheauWen.Lok@petermac.org
Contact person for public queries
Name 107507 0
Ms catherine morton
Address 107507 0
Walter and Eliza Hall Institute 1G Royal Parade Parkville VIC 3052
Country 107507 0
Australia
Phone 107507 0
+61 3 9345 2893
Fax 107507 0
Email 107507 0
catherine.morton2@mh.org.au
Contact person for scientific queries
Name 107508 0
Dr Sheau Wen Lok
Address 107508 0
Walter and Eliza Hall Institute 1G Royal Parade Parkville VIC 3052
Country 107508 0
Australia
Phone 107508 0
+61 3 9345 2555
Fax 107508 0
Email 107508 0
SheauWen.Lok@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.