Cardiotoxicity of Adjuvant Trastuzumab (CATS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shom Goel, Royal Prince Alfred Hospital, Sydney, Australia

ClinicalTrials.gov Identifier:

NCT00858039

First received: March 6, 2009

Last updated: November 4, 2014

Last verified: November 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

March 6, 2009

Last Updated Date

November 4, 2014

Start Date ^ICMJE

February 2009

Primary Completion Date

July 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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%) [ Time Frame: Until 6 months after completing trastuzumab ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00858039 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cardiotoxicity of Adjuvant Trastuzumab

Official Title ^ICMJE

Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Human serum Human whole blood

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to tertiary referral medical oncology clinics

Condition ^ICMJE

Breast Neoplasms
Heart Failure

Intervention ^ICMJE

Not Provided

Study Groups/Cohorts

Her-2 positive ESBC

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

220

Completion Date

June 2014

Primary Completion Date

July 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Exclusion Criteria:

Pregnancy
Distant metastases from breast cancer
Any systemic chemotherapy prior to study entry

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00858039

Other Study ID Numbers ^ICMJE

X08-0296

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Shom Goel, Royal Prince Alfred Hospital, Sydney, Australia

Study Sponsor ^ICMJE

Royal Prince Alfred Hospital, Sydney, Australia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Jane Beith, MBBS FRACP PhD

Sydney South West Area Health Service (Royal Prince Alfred Hospital)

PRS Account

Royal Prince Alfred Hospital, Sydney, Australia

Verification Date

November 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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