Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000153910
Ethics application status
Approved
Date submitted
3/02/2011
Date registered
9/02/2011
Date last updated
23/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Cardiac Changes During Chemotherapy in Breast Cancer
Scientific title
Early Cardiac Changes During Anthracycline and/or Trastuzumab Therapy in Breast Cancer
Secondary ID [1] 253546 0
None
Universal Trial Number (UTN)
U1111-1119-2755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chemotherapy induced Cardiomyopathy 261098 0
Breast Cancer 261126 0
Condition category
Condition code
Cardiovascular 259230 259230 0 0
Other cardiovascular diseases
Cancer 259231 259231 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cardiac MRI, Echocardiography, serum biomarkers at baseline, 1 month (during chemotherapy), 3 and 12 months (post chemotherapy). This will take approximately 90 minutes. We will perform these interventions to identify sub-clinical changes of probable significance for development of later manifest ventricular dysfunction.
Intervention code [1] 257994 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262067 0
Reduction in global longitudinal strain as measured by 2D speckle and Tissue velocity echocardiography (comparison will be made between baseline and 3 month scans).
Timepoint [1] 262067 0
baseline and 3 month scans
Secondary outcome [1] 273080 0
Presence and magnitude of myocardial fibrosis (as % of total LV mass) as assessed by 12 month CMR scan
Timepoint [1] 273080 0
12 month CMR scan
Secondary outcome [2] 273081 0
Presence and magnitude of myocardial oedema (as % of total LV mass) as assessed by 1 and 3 month CMR scan
Timepoint [2] 273081 0
1 and 3 month CMR scan
Secondary outcome [3] 273082 0
Reduction in global radial and circumferential strain as measured by 2D speckle and Tissue velocity echocardiography(comparison will be made between baseline and 3 month scans).
Timepoint [3] 273082 0
baseline and 3 month scans
Secondary outcome [4] 273083 0
Increase in Troponin T at 1 and 3 months, will be detected in a subset of patients that corresponds to increased signal intensity on STIR imaging and late gadolinium at 3 months
Timepoint [4] 273083 0
1 and 3 months

Eligibility
Key inclusion criteria
All patients with new diagnosis of HER2 positive early breast cancer planned for standard chemotherapy with anthracyclines and/or trastuzumab, or, patients with recurrent breast cancer planned for chemotherapy with anthracyclines and/or trastuzumab that have not had chemotherapy in the last 5 years.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with recurrent breast cancer that have received chemotherapy in the last 5 years, patients that don't meet safety requirements for cardiac MRI.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
SA
Recruitment postcode(s) [1] 3608 0
5042
Recruitment postcode(s) [2] 3609 0
5000
Recruitment postcode(s) [3] 3610 0
5037

Funding & Sponsors
Funding source category [1] 258427 0
Hospital
Name [1] 258427 0
Flinders Medical Centre
Address [1] 258427 0
Department Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country [1] 258427 0
Australia
Primary sponsor type
Individual
Name
Professor Joseph Selvanayagam
Address
Department Cardiovascular Medicine
Flinders Medical Centre
1 Flinders Drive
BEDFORD PARK
SA 5042
Country
Australia
Secondary sponsor category [1] 257575 0
None
Name [1] 257575 0
Address [1] 257575 0
Country [1] 257575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260410 0
The Southern Adelaide Health Service / Flinders University Human Research Ethics Committee
Ethics committee address [1] 260410 0
Human Research Ethics
Southern Adelaide Health Service
SA Health
Room 2A221 - Inside Human Resources
Flinders Medical Centre
1 Flinders Drive
Bedford Park
SA 5042
Ethics committee country [1] 260410 0
Australia
Date submitted for ethics approval [1] 260410 0
19/01/2010
Approval date [1] 260410 0
29/03/2010
Ethics approval number [1] 260410 0
24/10/2011

Summary
Brief summary
We wish to study and determine early predictors of cardiac toxicity during combined trastuzumab and/or anthracycline chemotherapy in patients with breast cancer by way of precise assessment of sub-clinical right (RV) and LV systolic and diastolic function. Volume measurements and determination of oedema and myocardial fibrosis will be performed by CMR and advanced echocardiography in order to identify sub-clinical changes of probably significance for development of later manifest ventricular dysfunction. Secondary aim is to correlate observed cardiovascular changes with cumulative dose chemotherapy, age and pre-existing cardiovascular risk factors and biochemical markers or cardiac dysfunction and fibrosis. We hypothesise that:
- CMR images will show evidence of myocardial oedema, before patients develop chemotherapy induced cardiomyopathy
- tagging imaging techniques will demonstrate lowered active diastolic function
- degree of cardiac dysfunction will be proportional to number of chemotherapy cycles conducted
- CMR and advanced echo will allow for identification of patients at high risk of heart disease
- Abnormalities seen on advanced echo and features of fibrosis on CMR will correspond with abnormal biochemical markers
Trial website
Trial related presentations / publications
. Grover S, Leong DP, Chakrabarty A, Joerg L, Kotasek D, Cheong K, Joshi R, Joseph MX, DePasquale C, Koczwara B, Selvanayagam JB. Left and right ventricular effects of anthracycline and trastuzumab chemotherapy: a prospective study using novel cardiac imaging and biochemical markers. Int J Cardiol. 2013;168(6):5465-7.
14. Grover S, Lou PW, Bradbrook C, Cheong K, Kotasek D, Leong DP, Koczwara B, Selvanayagam JB. Early and late changes in markers of aortic stiffness with breast cancer therapy. Int Med Journal. 2015 Feb;45(2):140-7.
Public notes

Contacts
Principal investigator
Name 32163 0
Prof Joseph Selvanayagam
Address 32163 0
Flinders Drive. Bedford Park, SA 5042
Country 32163 0
Australia
Phone 32163 0
+61 8 8204 5619
Fax 32163 0
Email 32163 0
joseph.selva@sa.gov.au
Contact person for public queries
Name 15410 0
Dr suchi grover
Address 15410 0
Flinders Clinical Research - Imaging
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042
Country 15410 0
Australia
Phone 15410 0
+61 8 8201 7700
Fax 15410 0
+61 8 8201 7701
Email 15410 0
kate.schwartz@health.sa.gov.au
Contact person for scientific queries
Name 6338 0
Dr Dr Suchi Grover
Address 6338 0
Flinders University
C/O Flinders Clinical Research - Imaging
Level 3A
Mark Oliphant Building
Laffer Drive
BEDFORD PARK
SA 5042
Country 6338 0
Australia
Phone 6338 0
+61 8 8201 7700
Fax 6338 0
+61 8 8201 7701
Email 6338 0
suchi.grover@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary