Cardiotoxicity of Adjuvant Trastuzumab (CATS)

November 4, 2014 updated by: Shom Goel, Royal Prince Alfred Hospital, Sydney, Australia

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Sydney, New South Wales, Australia, 2065
        • Royal North Shore Private Hospital
      • Sydney, New South Wales, Australia, 2077
        • Sydney Haematology Oncology Clinic
      • Sydney, New South Wales, Australia, 2137
        • Concord Hospital
      • Sydney, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Sydney, New South Wales, Australia, 2200
        • Bankstown Hospital
      • Sydney, New South Wales, Australia, 2217
        • St George private Hospital
      • Sydney, New South Wales, Australia, 2232
        • Sutherland Hospital
      • Sydney, New South Wales, Australia, 2560
        • Macarthur Cancer Therapy Centre
      • Sydney, New South Wales, Australia, 2750
        • Nepean Cancer Care Centre
      • Tweed Heads, New South Wales, Australia, 2485
        • Tweed Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane Hospital
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • Andrew Love Cancer Centre
      • Warnambool, Victoria, Australia
        • Warnambool Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6805
        • The Mount Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients presenting to tertiary referral medical oncology clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Her-2 positive ESBC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Until 6 months after completing trastuzumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Prince Alfred Hospital, Sydney, Australia

Investigators

  • Study Director: Jane Beith, MBBS FRACP PhD, Sydney South West Area Health Service (Royal Prince Alfred Hospital)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 6, 2009

First Submitted That Met QC Criteria

March 6, 2009

First Posted (Estimate)

March 9, 2009

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X08-0296

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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