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Cardiotoxicity of Adjuvant Trastuzumab (CATS)
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Purpose
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 |
|---|
| Breast Neoplasms Heart Failure |
| Study Type: | Observational |
| Study Design: | 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 |
- 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
| Enrollment: | 220 |
| Study Start Date: | February 2009 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Her-2 positive ESBC |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00858039
| 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 | |
| Study Director: | Jane Beith, MBBS FRACP PhD | Sydney South West Area Health Service (Royal Prince Alfred Hospital) |
More Information
| Responsible Party: | Shom Goel, Breast Oncology Fellow, Royal Prince Alfred Hospital, Sydney, Australia |
| ClinicalTrials.gov Identifier: | NCT00858039 History of Changes |
| Other Study ID Numbers: |
X08-0296 |
| Study First Received: | March 6, 2009 |
| Last Updated: | November 4, 2014 |
Additional relevant MeSH terms:
|
Heart Failure 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 Trastuzumab Antineoplastic Agents |
ClinicalTrials.gov processed this record on July 07, 2017