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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00858039




Registration number
NCT00858039
Ethics application status
Date submitted
6/03/2009
Date registered
6/03/2009
Date last updated
4/11/2014

Titles & IDs
Public title
Cardiotoxicity of Adjuvant Trastuzumab
Scientific title
Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab
Secondary ID [1] 0 0
X08-0296
Universal Trial Number (UTN)
Trial acronym
CATS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Her-2 positive ESBC -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cardiotoxicity (Cardiac death; grade 3/4 arrhythmia or ischaemia; NYHA Class 3 or 4 heart failure decline in LVEF by >10% to a level <55%; decline in LVEF by >5% to a level <50%)
Timepoint [1] 0 0
Until 6 months after completing trastuzumab

Eligibility
Key inclusion criteria
- Female 18 years or older

- Histologically confirmed, completely excised invasive breast cancer with Her-2
overexpression

- Primary surgery less than twelve weeks prior to registration

- LVEF>50% as assessed by transthoracic echocardiogram or gated heart pool scan

- Eastern Cooperative Oncology Group Performance Status 0-2

- Adjuvant systemic treatment plan comprises at least three cycles of anthracycline
chemotherapy AND 52 weeks of trastuzumab

- Before patient registration, informed consent must be given according to local
regulations.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnancy

- Distant metastases from breast cancer

- Any systemic chemotherapy prior to study entry

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Royal North Shore Private Hospital - Sydney
Recruitment hospital [3] 0 0
Sydney Haematology Oncology Clinic - Sydney
Recruitment hospital [4] 0 0
Concord Hospital - Sydney
Recruitment hospital [5] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [6] 0 0
Bankstown Hospital - Sydney
Recruitment hospital [7] 0 0
St George Private Hospital - Sydney
Recruitment hospital [8] 0 0
Sutherland Hospital - Sydney
Recruitment hospital [9] 0 0
Macarthur Cancer Therapy Centre - Sydney
Recruitment hospital [10] 0 0
Nepean Cancer Care Centre - Sydney
Recruitment hospital [11] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [12] 0 0
Royal Brisbane Hospital - Brisbane
Recruitment hospital [13] 0 0
Andrew Love Cancer Centre - Geelong
Recruitment hospital [14] 0 0
Warnambool Hospital - Warnambool
Recruitment hospital [15] 0 0
The Mount Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2077 - Sydney
Recruitment postcode(s) [4] 0 0
2137 - Sydney
Recruitment postcode(s) [5] 0 0
2170 - Sydney
Recruitment postcode(s) [6] 0 0
2200 - Sydney
Recruitment postcode(s) [7] 0 0
2217 - Sydney
Recruitment postcode(s) [8] 0 0
2232 - Sydney
Recruitment postcode(s) [9] 0 0
2560 - Sydney
Recruitment postcode(s) [10] 0 0
2750 - Sydney
Recruitment postcode(s) [11] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [12] 0 0
4029 - Brisbane
Recruitment postcode(s) [13] 0 0
3220 - Geelong
Recruitment postcode(s) [14] 0 0
- Warnambool
Recruitment postcode(s) [15] 0 0
6805 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Prince Alfred Hospital, Sydney, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing
early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting
(anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of
patients. Patients who develop heart problems when taking trastuzumab might have to stop this
treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic
peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of
which have been shown to indicate the presence of heart failure. Some early research has
suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to
cancer chemotherapy and also trastuzumab. Troponin is another substance measured in the blood
that can indicate heart damage. Finally, certain variations in an individual's genetic makeup
(called polymorphisms) could put them at increased risk of heart damage from trastuzumab.
Here we are studying whether any of these factors (NT pro-BNP levels, troponin levels, or
certain genetic polymorphisms) can accurately predict who is at highest risk of
trastuzumab-related cardiotoxicity.

The principal aim of this study is to evaluate the utility of NT pro-BNP as a predictive
biomarker for the development of trastuzumab related cardiotoxicity (TRC). The investigators
will also examine if single nucleotide polymorphisms in the HER2 gene or Fc-gamma-receptor
genes predict for TRC.
Trial website
https://clinicaltrials.gov/show/NCT00858039
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jane Beith, MBBS FRACP PhD
Address 0 0
Sydney South West Area Health Service (Royal Prince Alfred Hospital)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications