Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00858039
Ethics application status
Date submitted
6/03/2009
Date registered
9/03/2009
Date last updated
5/11/2014

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
Cancer 0 0 0 0
Breast
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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
Sex
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
1/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
Accrual to date
Final
220
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
Trial website
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

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00858039