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Cardiotoxicity of Adjuvant Trastuzumab (CATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00858039
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Shom Goel, Royal Prince Alfred Hospital, Sydney, Australia

Study Description
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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
Breast Neoplasms Heart Failure

Study Design
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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 : February 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
Her-2 positive ESBC


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

Biospecimen Retention:   Samples With DNA
Human serum Human whole blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to tertiary referral medical oncology clinics
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858039


Locations
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Australia, New South Wales
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Royal North Shore Private Hospital
Sydney, New South Wales, Australia, 2065
Sydney Haematology Oncology Clinic
Sydney, New South Wales, Australia, 2077
Concord Hospital
Sydney, New South Wales, Australia, 2137
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
Bankstown Hospital
Sydney, New South Wales, Australia, 2200
St George Private Hospital
Sydney, New South Wales, Australia, 2217
Sutherland Hospital
Sydney, New South Wales, Australia, 2232
Macarthur Cancer Therapy Centre
Sydney, New South Wales, Australia, 2560
Nepean Cancer Care Centre
Sydney, New South Wales, Australia, 2750
Tweed Hospital
Tweed Heads, New South Wales, Australia, 2485
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Andrew Love Cancer Centre
Geelong, Victoria, Australia, 3220
Warnambool Hospital
Warnambool, Victoria, Australia
Australia, Western Australia
The Mount Hospital
Perth, Western Australia, Australia, 6805
Sponsors and Collaborators
Royal Prince Alfred Hospital, Sydney, Australia
Investigators
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Study Director: Jane Beith, MBBS FRACP PhD Sydney South West Area Health Service (Royal Prince Alfred Hospital)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: March 9, 2009    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Breast Neoplasms
Cardiotoxicity
Heart Diseases
Cardiovascular Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries