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Trial registered on ANZCTR


Registration number
ACTRN12620000628943
Ethics application status
Approved
Date submitted
7/04/2020
Date registered
29/05/2020
Date last updated
29/05/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Patients with Advanced TRIple Negative Breast Cancer in Australia
Scientific title
Patients with Advanced TRIple Negative Breast Cancer in Australia. To evaluate the clinical presentation, treatment patterns and outcomes of patients with newly or recently diagnosed advanced TNBC managed in routine clinical practice.
Secondary ID [1] 296727 0
Not available
Universal Trial Number (UTN)
None
Trial acronym
PATRICIA
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 316974 0
Condition category
Condition code
Cancer 315135 315135 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
Triple negative breast cancers (TNBCs) account for approximately 15-20% of new breast cancer diagnoses. They are characterised by a lack of oestrogen, progesterone and human epidermal growth factor receptor 2 (HER2) receptor expression and mostly comprise the basal-like molecular subtype, although substantial heterogeneity exists within TNBCs. Clinically, TNBCs typically exhibit an aggressive phenotype and are associated with a higher risk of relapse within the first two years of diagnosis of early breast cancer. This is observed even though patients with early stage TNBC appear to derive greater proportional benefits from systemic chemotherapy than patients with ER-positive early stage breast cancer. Patients with advanced TNBC have a poorer prognosis compared to patients with other breast cancer subtypes (Reddy et al, 2018) in terms of both breast cancer specific survival and overall survival (OS), with a median OS of approximately 16 months.

Treatment standards that guide the management of breast cancer in clinical practice are typically defined in prospective clinical trials. However, the selected patients who are enrolled in such clinical trials often differ from patients seen in a routine practice setting, with elderly breast cancer patients significantly underrepresented in the study population, and patients with ECOG performance status of two or higher are also excluded. Thus, the translation of data for emerging breast cancer therapies to a general patient population is challenging.

There is also a paucity of data relating to how various chemotherapy agents are utilised in patients with advanced TNBC in routine practice in terms of sequencing and combination, and how these variations in practice might influence patient outcomes.

This study will enable collection of real world data of patients with newly diagnosed advanced TNBC to improve understanding of the presentation, disease outcomes and treatment decisions made in the real world setting.

Participants will not be required to have any extra tests or procedures, there will be no involvement from them just an audit of their records.
Intervention code [1] 317275 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323405 0
Measuring Progression Free Survival (PFS) for 1st, 2nd and 3rd line systemic therapy as per medical records . This is a composite outcome.
Timepoint [1] 323405 0
There is no fixed timepoint as it will vary from one participant to another.
Secondary outcome [1] 381839 0
Measurement of time to treatment failure (TTF) for specific regimens in the 1st, 2nd and 3rd line systemic therapy as per medical records. This is a composite outcome.
Timepoint [1] 381839 0
There is no fixed timepoint as it will vary from one participant to another.
Secondary outcome [2] 381840 0
Measurement of Disease Free Interval (DFI) in the subset of patients with relapsed TNBC as per medical records.
Timepoint [2] 381840 0
No fixed timepoint as it varies from patient to patient.
Secondary outcome [3] 381841 0
Measurement of Overall survival (OS) as per medical records
Timepoint [3] 381841 0
No fixed timepoint as it varies from patient to patient.
Secondary outcome [4] 381842 0
Measurement of rates of pCR in patients who received neoadjuvant systemic therapy for early stage TNBC as per medical records.
Timepoint [4] 381842 0
Varies from patient to patient
Secondary outcome [5] 381843 0
Incidence of BRCA mutations in patients with TNBC
Timepoint [5] 381843 0
From records at time of enrolment
Secondary outcome [6] 382985 0
5. To estimate the average duration of each line of therapy in the 1st, 2nd and 3rd line treatment settings as per medical records
Timepoint [6] 382985 0
Varies from patient to patient.

Eligibility
Key inclusion criteria
1. Patients of any age, gender and ECOG performance status diagnosed with metastatic, or inoperable TNBC (either relapsed or de novo metastatic), after 1st July 2018.

2. Histological or cytological confirmation of TNBC [defined as absence of HER2, ER and progesterone receptor (PR) expression] from either the primary archival tissue or from biopsy material obtained from a metastatic site.

ER and PR negativity are defined as <1% of cells expressing hormonal receptors via immunohistochemistry (IHC) analysis
HER2 negativity by local laboratory assessment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
In order to compare clinical outcomes across different subgroups, Kaplan-Meier survival curves will be defined from survival data and constructed using SAS® software (SAS Institute Inc., Cary, NC, USA). 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16393 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 16394 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 29937 0
3084 - Heidelberg
Recruitment postcode(s) [2] 29938 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 301308 0
Commercial sector/Industry
Name [1] 301308 0
Roche Products Pty Limited
Address [1] 301308 0
Level 8, 30-34 Hickson Road
Sydney NSW 2000
Country [1] 301308 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] 300964 0
None
Name [1] 300964 0
Address [1] 300964 0
Country [1] 300964 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302049 0
Melbourne Health HREC
Ethics committee address [1] 302049 0
Office for Research
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 302049 0
Australia
Date submitted for ethics approval [1] 302049 0
Approval date [1] 302049 0
23/03/2020
Ethics approval number [1] 302049 0

Summary
Brief summary
This is a multi-centre prospective cohort study to collect data related to the management of metastatic triple negative breast cancer (TNBC) in a routine clinical practice patient population,
Who is it for?
Patients of any age, gender and ECOG performance status diagnosed with metastatic, or inoperable TNBC (either relapsed or newly diagnosed metastatic disease), after 1st July 2018.
Study details
It is intended to collect real world data on the duration of therapy, the rationale for any change in treatment and uptake of targeted therapies or immunotherapy. This study will also collect comprehensive data on any treatment received in the (neo) adjuvant setting given that the type of chemotherapy regimen selected often impacts on treatment decisions in the metastatic setting. Where applicable, data on trimodality treatment of primary breast cancer and metastatic disease will also be recorded.
Patients will not be required to do anything extra, we will just be collecting, demographics (age, any other diseases you have, how well you feel) whether you have had a test to check any gene mutations, like BRCA, where your cancer has spread to and any treatment information (chemotherapy, surgery, radiotherapy).
This study will give us real life information about how various chemotherapy and other treatments are used in patients with advanced TNBC in routine practice in terms of when and in what combination, and how these variations in practice might influence patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88958 0
Dr Richard De Boer
Address 88958 0
Melbourne Health
305 Grattan Street
Melbourne VIC 3000
Australia
Country 88958 0
Australia
Phone 88958 0
+61 3 8559 5000
Fax 88958 0
Email 88958 0
Richard.DeBoer@wh.org.au
Contact person for public queries
Name 88959 0
Ms Catherine Morton
Address 88959 0
Walter and Eliza Hall Institute
1G Royal Parade
Parkville
VIC 3052
Country 88959 0
Australia
Phone 88959 0
+61 3 9345 2555
Fax 88959 0
Email 88959 0
Catherine.Morton2@mh.org.au
Contact person for scientific queries
Name 88960 0
Dr Sheau Wen Lok
Address 88960 0
Walter and Eliza Hall Institute
1G Royal Parade
Parkville
VIC 3052
Country 88960 0
Australia
Phone 88960 0
+61 3 9345 2555
Fax 88960 0
Email 88960 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
The primary objective of the study is to evaluate the clinical presentation, treatment patterns and outcomes of patients with newly or recently diagnosed advanced TNBC managed in routine clinical practice. Therefore, aggregated results will be more meaningful than IPD.
What supporting documents are/will be available?
No other documents available
Summary results
No Results