Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000504213
Ethics application status
Approved
Date submitted
12/02/2009
Date registered
23/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac monitoring with echocardiogram and tissue doppler imaging (TDI) and serum biomarkers to assess for cardiotoxicity with anthracyclines in women during adjuvant chemotherapy for breast cancer.
Scientific title
Cardiac monitoring with echocardiogram and tissue doppler imaging (TDI) and serum biomarkers to assess for cardiotoxicity with anthracyclines in women during adjuvant chemotherapy for breast cancer.
Universal Trial Number (UTN)
Trial acronym
ECHO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 4322 0
Condition category
Condition code
Cancer 4557 4557 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Biomarkers, electrocardiogram (ECG) and echocardiogram will be done at baseline (before chemotherapy), after cycle1, cycle 3 and 6 month post start day of chemotherapy. Cardiac biomarkers are study specific blood tests taken to assess and correlate changes in heart function with changes in heart function as measured by TDI or as measured by ejection fraction. An electrocardiogram (ECG) measures the electrical activity of the heart. The test takes about 10 minutes. Patients are usually given 4 to 6 cycles of chemotherapy. One cyle lasts 3 weeks. Chemotherapy treatment may vary depending on patient's treatment plan. Some of tha drugs that may be administred are: Epirubuicn, 5-Fluorouracil, Cyclophosphamide, Taxotere.
Intervention code [1] 4052 0
Not applicable
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5435 0
To determine if quantitative assessment of myocardial function with TDI is more sensitive than changes in left ventricular ejection fraction for detecting early cardiomyopathy in breast cancer patients receiving anthracycline based chemotherapy.This will be assessed by performing study procedures and monitoring be the investigators. See the timepoints below.
Timepoint [1] 5435 0
At four diferrent timepoints during chemotherapy treatment: pre chemotherapy, post cycle 1, post cycle 3 and 6 months post chemotherapy.
Primary outcome [2] 5436 0
To determine if the biochemical markers Troponin I and B-type natriuretic peptide (BNP) co-relate more closely to changes in myocardial TDI velocities than they do with changes in LV ejection fraction. This will be assessed by performing study procedures and monitoring be the investigators. See the timepoints below.
Timepoint [2] 5436 0
At four diferrent timepoints during chemotherapy treatment: pre chemotherapy, pre cycle 2, post cylce 3 and 6 months post chemotherapy.
Secondary outcome [1] 9134 0
To determine if changes in the TDI or Troponin I and BNP are able to identify preclinical changes of cardiac function. This will be assessed by performing study procedures and monitoring be the investigators. See the timepoints below.
Timepoint [1] 9134 0
At four diferrent timepoints during chemotherapy treatment: pre chemotherapy, pre cycle 2, post cylce 3 and 6 months post chemotherapy.

Eligibility
Key inclusion criteria
1.Histologically or cytologically proven invasive adenocarcinoma of the breast.
2.Early stage breast cancer T1-T4, any N Mo considered suitable for adjuvant chemotherapy.
3.Planned to receive at least 3 cycles of anthracycline based chemotherapy.
4.Age > 18 years.
5.Karnofsky Performance status index > 80%.
6.Routine laboratory requirements (within 28 days prior to registration):
Haematology:
- Neutrophils > 1.5 x 109/L
- Platelets >100 x 109/L
- Haemoglobin > 10 g/dL.
Hepatic function:
- Total bilirubin < 1 Upper Normal Limit (UNL) (patients with a well documented history of Gilbert’s Syndrome are eligible)
- Aspartate transaminase (ASAT, SGOT) and AAlanine transaminase (ALAT, SGPT) < 2.5 UNL
- Alkaline phosphatase < 5 UNL.
Renal function:
- Creatinine < 175 micro mol/L (2 mg/dL).

7.Negative pregnancy test (urine or serum) within 7 days prior to registration for all women of childbearing potential.
8.Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Prior or concurrent systemic anticancer therapy for breast cancer (immunotherapy, hormone therapy, biological, or chemotherapy).
2.Prior or concurrent radiation therapy for breast cancer.
3.Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment.
4.M1 breast cancer.
5.Serious cardiac medical condition including but not limited to: Congestive Heart Failure; unstable angina pectoris; previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or high-risk uncontrolled arrhythmias.
6.Other serious illness or medical condition including but not limited to: active uncontrolled infection; active peptic ulcer; unstable diabetes mellitus; dementia or seizures that would prohibit the understanding of giving informed consent;
7.History of significant neurological or psychiatric disorders including psychotic disorders.
8.Current history of any neoplasm other than breast carcinoma.
9.Concurrent treatment with other experimental drugs.
10.Known allergy reactions or excipients used in the study.
11.Male patients.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4494 0
Government body
Name [1] 4494 0
Victorian Cancer Agency
Country [1] 4494 0
Australia
Primary sponsor type
Other
Name
Southern Health
Address
865 Centre Road
EAST BENTLEIGH VIC 3165
Country
Australia
Secondary sponsor category [1] 4057 0
None
Name [1] 4057 0
Address [1] 4057 0
Country [1] 4057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6554 0
Southern Helath Human Research Ethics Committee
Ethics committee address [1] 6554 0
Research Support Unit
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 6554 0
Australia
Date submitted for ethics approval [1] 6554 0
01/05/2008
Approval date [1] 6554 0
22/09/2008
Ethics approval number [1] 6554 0
08061A

Summary
Brief summary
The risk of cardiomyopathy as a side-effect is related to the total dose of anthracycline given to a patient. Cardiomyopathy may in turn cause symptoms of heart failure such as shortness of breath, increased tiredness, swelling of your ankles, inability to keep up your usual level of activity. These symptoms may be serious and even permanent.

Current practice is to ensure normal heart function before starting anthracycline therapy. This is done using one of two available techniques: echocardiogram or gated cardiac blood pool scan (GCBPS). An echocardiogram uses ultrasound whereas a GCBPS uses a radioactive isotope. Use of a radioactive isotope means exposure to a small amount of radiation and a small risk of allergic reaction to the isotope. Current practice is to repeat one of these two tests only if the patient later experiences any symptoms of heart failure.

The aim of this study is to assess whether a newer technique using Tissue Doppler Imaging (TDI) is more sensitive in detecting early changes in heart function. The study also examines whether changes in specific blood tests (known as cardiac biomarkers) correlate more closely to changes in heart function as measured by TDI or as measured by echocardiogram..

The use of TDI measurement as a technique is not proven in the monitoring of patients that receive anthracycline therapy and so is investigational in nature. For the purposes of this study heart function for all patients will be measured using echocardiogram and TDI. This will be done as one procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29281 0
Address 29281 0
Country 29281 0
Phone 29281 0
Fax 29281 0
Email 29281 0
Contact person for public queries
Name 12528 0
Kim Brewin
Address 12528 0
865 Centre Road
EAST BENTLEIGH VIC 3165
Country 12528 0
Australia
Phone 12528 0
+61 3 9928 8350
Fax 12528 0
+ 61 3 9928 8341
Email 12528 0
[email protected]
Contact person for scientific queries
Name 3456 0
Dr Michelle White
Address 3456 0
865 Centre Road
EAST BENTLEIGH VIC 3165
Country 3456 0
Australia
Phone 3456 0
+ 61 3 9928 8120
Fax 3456 0
+ 61 3 9928 8341
Email 3456 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

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