Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000232538
Ethics application status
Approved
Date submitted
24/02/2015
Date registered
13/03/2015
Date last updated
13/03/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Advanced Breast Cancer in the Human Epidermal Growth Factor Receptor 2 (HER2) Positive Australian Patient
Scientific title
A study to develop a prospective multi-site registry to evaluate clinical features, types of treatment, outcomes and survival in participants with HER2 positive metastatic breast cancer managed in routine practice in Australia
Secondary ID [1] 286242 0
None
Universal Trial Number (UTN)
U1111-1167-5326
Trial acronym
TABITHA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER2 positive metastatic breast cancer 294293 0
Condition category
Condition code
Cancer 294614 294614 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
This is an observational/non-interventional study.
The factors to be observed include the type of clinical characteristics of participants, such as age at diagnosis, performance status, and comorbidities; the type of tumour characteristics such as rate of hormone receptor positivity, sites of metastatic disease at diagnosis, rate of brain metastases at any time during the disease course, and time to relapse in participants with past history of early stage breast cancer; treatment patterns including the choice of HER2 agent for 1st, 2nd and 3rd line settings, choice of chemotherapy agent to be used in combination with HER2 therapy, and rate of treatment with trastuzumab beyond disease progression; and survival including overall survival and progression free survival in 1st, 2nd and 3rd line settings.
Intervention code [1] 291257 0
Not applicable
Comparator / control treatment
This registry will include all consecutive patients with HER2 positive metastatic breast cancer, who will differ in clinical characteristics, and for which treatment choice and efficacy will vary. Comparator groups will be derived from the data captured in the registry based on the specific observation or characteristic of interest (e.g. comparison of outcomes in participants aged <70 years vs. aged at least 70 years or participants who do vs. do not receive trastuzumab as 1st line treatment).
Control group
Active

Outcomes
Primary outcome [1] 294379 0
To evaluate the clinical characteristics of consecutive patients with newly or recently diagnosed HER2+ metastatic breast cancer managed in routine clinical practice in Australia.
Clinical data will be captured prospectively at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, as well as comparisons between clinical characteristics of interest using the Chi Square method.
Timepoint [1] 294379 0
5 years
Primary outcome [2] 294442 0
To evaluate the treatment selection for 1st, 2nd and 3rd lines of systemic treatment of consecutive patients with newly or recently diagnosed HER2+ metastatic breast cancer managed in routine clinical practice in Australia. Data on treatment selection will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, as well as comparisons between treatment patterns of interest using the Chi Square method.
Timepoint [2] 294442 0
5 years
Primary outcome [3] 294443 0
To evaluate the survival outcomes in 1st, 2nd and 3rd systemic treatment line settings of consecutive patients with newly or recently diagnosed HER2+ metastatic breast cancer managed in routine clinical practice in Australia.
Survival data will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined acrss all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, with survival estimated by the Kaplan Meier method, and compared using the Mantel-Cox log-rank test.
Timepoint [3] 294443 0
5 years
Secondary outcome [1] 313153 0
To describe treatment patterns for patients with HER2+ metastatic breast cancer managed in routine clinical practice in Australia including:
a) The impact of age, co-morbidity and performance status on clinicians’ treatment selection
b) The proportion of patients with HER2+ MBC who do not receive systemic therapy
c) The common chemotherapy regimens prescribed in combination with anti-HER2 therapies and the sequencing of agents for HER2+ MBC across 1st, 2nd and 3rd lines of treatment
d) The average duration of chemotherapy and anti-HER2 therapy in the 1st, 2nd and 3rd line treatment settings
e) Variations in practice and treatment selection across different treatment locations, including private vs. public and metropolitan vs. regional settings
Clinical and treatment data will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, as well as comparisons between characteristics of interest using the Chi Square method.
Timepoint [1] 313153 0
5 years
Secondary outcome [2] 313154 0
To determine the progression free survival in 1st, 2nd and 3rd line treatment in patients with HER2+ metastatic breast cancer managed in routine clinical practice in Australia.
Survival data will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, with survival estimated by the Kaplan Meier method, and compared using the Mantel-Cox log-rank test.
Timepoint [2] 313154 0
5 years
Secondary outcome [3] 313155 0
To determine the overall survival in patients with HER2+ metastatic breast cancer managed in routine clinical practice in Australia.
Survival data will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, with survival estimated by the Kaplan Meier method, and compared using the Mantel-Cox log-rank test.
Timepoint [3] 313155 0
5 years
Secondary outcome [4] 313156 0
To determine the incidence, timing of treatment and outcomes of brain metastases in patients with HER2+ metastatic breast cancer treated in routine clinical practice in Australia
Data relating to the presentation and treatment of brain metastases will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, as well as comparisons between clinical characteristics of patients with and without brain metastatses using the Chi Square method.
Timepoint [4] 313156 0
5 years
Secondary outcome [5] 313157 0
To determine the rate of HER2-therapy-associated cardiotoxicity patients with HER2+ metastatic breast cancer treated in routine clinical practice in Australia.
Data relating to rate and severity of cardiotoxicity will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed, as well as comparisons between toxicity rates using the Chi Square method.
Timepoint [5] 313157 0
5 years
Secondary outcome [6] 313173 0
To determine the proportion and characteristics of patients with relapsed breast cancer who undergo tissue biopsy of metastatic disease.
Data relating to receptor expression in primary and metastatic breast cancer will be captured at point-of care and entered by treating clinicians into an electronic secured database. Data will be extracted in de-identified (coded) format by BioGrid Australia and combined across all participating sites. Analyses will be performed after data linkage on de-identified (coded) data only.
Descriptive analyses will be performed to describe rate of discordance in receptor status in metastatic and primary breast cancer. Comparisons between participants with and without discordant receptor expression will be made using the Chi Square method.
Timepoint [6] 313173 0
5 years

Eligibility
Key inclusion criteria
Patients of any age and any level of fitness with HER2+ metastatic breast cancer, of any hormone receptor status, either recurrent or de novo metastatic disease, who have either been diagnosed with metastatic disease within the last 3-6 months or who have progressed on 1st line therapy in the last 3-6 months
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with HER2+ metastatic breast cancer who have received more than two lines of therapy already
- Patients who are not Australian citizens or are otherwise ineligible for systemic treatment subsidised by the Pharmaceutical Benefit Scheme

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
As the aim of this study is to better understand the treatment and outcomes of HER2+ metastatic breast cancer for which there is currently very little data in a ‘real world’ setting, there is no formal statistical plan. It is anticipated that a sample size of 300 is sufficient to achieve the aim of this study, and to achieve preliminary insights into variation in practice and outcomes across sites

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2015
Actual
10/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290800 0
Commercial sector/Industry
Name [1] 290800 0
Roche Products Pty Ltd
Country [1] 290800 0
Australia
Primary sponsor type
Other Collaborative groups
Name
BioGrid Australia Ltd
Address
6 North, Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 289481 0
None
Name [1] 289481 0
Address [1] 289481 0
Country [1] 289481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292426 0
Melbourne Health HREC
Ethics committee address [1] 292426 0
Grattan Street
Parkville
VIC 3052
Ethics committee country [1] 292426 0
Australia
Date submitted for ethics approval [1] 292426 0
11/02/2015
Approval date [1] 292426 0
03/03/2015
Ethics approval number [1] 292426 0
15MH/8

Summary
Brief summary
This study will collect data related to the management of women and men with HER2 positive metastatic breast cancer who are treated in routine clinical practice.

Who is it for?
You may be eligible to join this study if you are a patient of any age and any level of fitness with HER2+ metastatic breast cancer, of any hormone receptor status, either recurrent or de novo metastatic disease, who has either been diagnosed with metastatic disease within the last 3-6 months or who has progressed on 1st line therapy in the last 3-6 months.

Study details
For all patients enrolled in this study, data will be collected on the types of anti-HER2 therapies and chemotherapies used, how long treatment is given for, reasons for any changes in treatment, the impact of anti-HER2 therapies on heart function, and how often certain parts of the body, including the brain, are affected by HER2+ metastatic breast cancer. No personal/identifying data will be collected.

This study will help to improve our knowledge of the way that HER2+ metastatic breast cancer behaves, what types of treatment are effective, and the risks and benefits of these treatments within usual clinical practice conditions, with the aim of guiding future research of this disease and improving the outcomes for anyone affected by HER2+ metastatic breast cancer. All collected data will be compiled in a registry, which will be managed by BioGrid Australia. BioGrid Australia is a non-profit company that was set up to help with data collection and analyses for medical research.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55238 0
A/Prof Peter Gibbs
Address 55238 0
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3052
Country 55238 0
Australia
Phone 55238 0
+61 3 93427560
Fax 55238 0
Email 55238 0
[email protected]
Contact person for public queries
Name 55239 0
Mr Michael Harold
Address 55239 0
6 North, Royal Melbourne Hospital
300 Grattan St
Parkville VIC 3050
Country 55239 0
Australia
Phone 55239 0
+61 3 93427066
Fax 55239 0
Email 55239 0
[email protected]
Contact person for scientific queries
Name 55240 0
Dr Natalie Turner
Address 55240 0
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville VIC 3052
Country 55240 0
Australia
Phone 55240 0
+61 3 9345 2893
Fax 55240 0
Email 55240 0
[email protected]

No information has been provided regarding IPD availability


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.