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CATS: Cardiotoxicity of Adjuvant Trastuzumab

Sponsor
Royal Prince Alfred Hospital, Sydney, Australia (Other)
Overall Status
Completed
CT.gov ID
NCT00858039
Collaborator
(none)
220
Enrollment
15
Locations
63.9
Duration (Months)
14.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    220 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab
    Study Start Date :
    Feb 1, 2009
    Actual Primary Completion Date :
    Jul 1, 2013
    Actual Study Completion Date :
    Jun 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Her-2 positive ESBC

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Prince Alfred Hospital Sydney New South Wales Australia 2050
    2 Royal North Shore Private Hospital Sydney New South Wales Australia 2065
    3 Sydney Haematology Oncology Clinic Sydney New South Wales Australia 2077
    4 Concord Hospital Sydney New South Wales Australia 2137
    5 Liverpool Hospital Sydney New South Wales Australia 2170
    6 Bankstown Hospital Sydney New South Wales Australia 2200
    7 St George Private Hospital Sydney New South Wales Australia 2217
    8 Sutherland Hospital Sydney New South Wales Australia 2232
    9 Macarthur Cancer Therapy Centre Sydney New South Wales Australia 2560
    10 Nepean Cancer Care Centre Sydney New South Wales Australia 2750
    11 Tweed Hospital Tweed Heads New South Wales Australia 2485
    12 Royal Brisbane Hospital Brisbane Queensland Australia 4029
    13 Andrew Love Cancer Centre Geelong Victoria Australia 3220
    14 Warnambool Hospital Warnambool Victoria Australia
    15 The Mount Hospital Perth Western Australia Australia 6805

    Sponsors and Collaborators

    • Royal Prince Alfred Hospital, Sydney, Australia

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shom Goel, Breast Oncology Fellow, Royal Prince Alfred Hospital, Sydney, Australia
    ClinicalTrials.gov Identifier:
    NCT00858039
    Other Study ID Numbers:
    • X08-0296
    First Posted:
    Mar 9, 2009
    Last Update Posted:
    Nov 5, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Breast Neoplasms
    Cardiotoxicity

    Study Results

    No Results Posted as of Nov 5, 2014