Cardiotoxicity of Adjuvant Trastuzumab

Heart Failure Clinical Trial

— CATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858039
• Other study ID #: X08-0296
• Status: Completed
• Phase: N/A
• First received: March 6, 2009
• Last updated: November 4, 2014
• Start date: February 2009
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Royal Prince Alfred Hospital, Sydney, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: June 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Heart Failure

Locations

Country	Name	City	State
Australia	Royal Brisbane Hospital	Brisbane	Queensland
Australia	Andrew Love Cancer Centre	Geelong	Victoria
Australia	The Mount Hospital	Perth	Western Australia
Australia	Bankstown Hospital	Sydney	New South Wales
Australia	Concord Hospital	Sydney	New South Wales
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	Macarthur Cancer Therapy Centre	Sydney	New South Wales
Australia	Nepean Cancer Care Centre	Sydney	New South Wales
Australia	Royal North Shore Private Hospital	Sydney	New South Wales
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	St George Private Hospital	Sydney	New South Wales
Australia	Sutherland Hospital	Sydney	New South Wales
Australia	Sydney Haematology Oncology Clinic	Sydney	New South Wales
Australia	Tweed Hospital	Tweed Heads	New South Wales
Australia	Warnambool Hospital	Warnambool	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Royal Prince Alfred Hospital, Sydney, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%)		Until 6 months after completing trastuzumab	Yes