Spots Global Cancer Trial Database for Cardiotoxicity of Adjuvant Trastuzumab
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Trial Identification
Brief Title: Cardiotoxicity of Adjuvant Trastuzumab
Official Title: Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab
Study ID: NCT00858039
Interventions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
Royal North Shore Private Hospital, Sydney, New South Wales, Australia
Sydney Haematology Oncology Clinic, Sydney, New South Wales, Australia
Concord Hospital, Sydney, New South Wales, Australia
Liverpool Hospital, Sydney, New South Wales, Australia
Bankstown Hospital, Sydney, New South Wales, Australia
St George Private Hospital, Sydney, New South Wales, Australia
Sutherland Hospital, Sydney, New South Wales, Australia
Macarthur Cancer Therapy Centre, Sydney, New South Wales, Australia
Nepean Cancer Care Centre, Sydney, New South Wales, Australia
Tweed Hospital, Tweed Heads, New South Wales, Australia
Royal Brisbane Hospital, Brisbane, Queensland, Australia
Andrew Love Cancer Centre, Geelong, Victoria, Australia
Warnambool Hospital, Warnambool, Victoria, Australia
The Mount Hospital, Perth, Western Australia, Australia
Contact Details
Name: Jane Beith, MBBS FRACP PhD
Affiliation: Sydney South West Area Health Service (Royal Prince Alfred Hospital)
Role: STUDY_DIRECTOR
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