Trial Review

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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
Sex
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
29/07/2010
Actual
5/08/2010
Date of last participant enrolment
Anticipated
Actual
12/10/2012
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
100
Accrual to date
Final
50
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 15410 0
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
[email protected]
Contact person for scientific queries
Name 6338 0
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
[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.