Breast NeoplasmsCATSNCT00858039
Cardiotoxicity of Adjuvant Trastuzumab
An observational study of Breast Neoplasms and Heart Failure, run by Royal Prince Alfred Hospital, Sydney, Australia at 15 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Heart Failure
- How many people
- 220 participants
- Where
- 15 sitesAustralia
- Study dates
- Feb 2009to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to tertiary referral medical oncology clinics
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Distant metastases from breast cancer
- Any systemic chemotherapy prior to study entry
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Australia15 sites
Royal Brisbane Hospital
Brisbane, Queensland, 4029
Andrew Love Cancer Centre
Geelong, Victoria, 3220
The Mount Hospital
Perth, Western Australia, 6805
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Royal North Shore Private Hospital
Sydney, New South Wales, 2065
Sydney Haematology Oncology Clinic
Sydney, New South Wales, 2077
Concord Hospital
Sydney, New South Wales, 2137
Liverpool Hospital
Sydney, New South Wales, 2170
Bankstown Hospital
Sydney, New South Wales, 2200
St George Private Hospital
Sydney, New South Wales, 2217
Sutherland Hospital
Sydney, New South Wales, 2232
Macarthur Cancer Therapy Centre
Sydney, New South Wales, 2560
Nepean Cancer Care Centre
Sydney, New South Wales, 2750
Tweed Hospital
Tweed Heads, New South Wales, 2485
Warnambool Hospital
Warrnambool, Victoria
About this study
Official title: 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.
- Conditions
- Breast Neoplasms, Heart Failure
- Medical subject headings
- Breast Neoplasms, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Her-2 positive ESBC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: Until 6 months after completing trastuzumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Prince Alfred Hospital, Sydney, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shom Goel, Royal Prince Alfred Hospital, Sydney, Australia
- Investigators
- Jane Beith, MBBS FRACP PhD, Study director, Sydney South West Area Health Service (Royal Prince Alfred Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858039
- Sponsor's protocol ID
- X08-0296
- Acronym
- CATS
- Status last verified
- Nov 2014
- First submitted
- 6 Mar 2009
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Goel S, Liu J, Guo H, Barry W, Bell R, Murray B, Lynch J, Bastick P, Chantrill L, Kiely BE, Abdi E, Rutovitz J, Asghari R, Sullivan A, Harrison M, Kohonen-Corish M, Beith J. Decline in Left Ventricular Ejection Fraction Following Anthracyclines Predicts Trastuzumab Cardiotoxicity. JACC Heart Fail. 2019 Sep;7(9):795-804. doi: 10.1016/j.jchf.2019.04.014. Epub 2019 Aug 7.
PubMed 31401102
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Cardiotoxicity Using Serum N-terminal Pro-B-type Natriuretic Peptide in Breast Cancer Patients Receiving Adjuvant Trastuzumab
- ClinicalTrials.gov ID
- NCT00858039
- Acronym / sponsor ID
- CATS / X08-0296
- Conditions
- Breast Neoplasms, Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Royal Prince Alfred Hospital, Sydney, AustraliaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Her-2 positive ESBC | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to tertiary referral medical oncology clinics
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Distant metastases from breast cancer
- Any systemic chemotherapy prior to study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Derived from this study: PubMed 31401102Goel S, Liu J, Guo H, Barry W, Bell R, Murray B, Lynch J, Bastick P, Chantrill L, Kiely BE, Abdi E, Rutovitz J, Asghari R, Sullivan A, Harrison M, Kohonen-Corish M, Beith J. Decline in Left Ventricular Ejection Fraction Following Anthracyclines Predicts Trastuzumab Cardiotoxicity. JACC Heart Fail. 2019 Sep;7(9):795-804. doi: 10.1016/j.jchf.2019.04.014. Epub 2019 Aug 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Beith, MBBS FRACP PhD study director
Sydney South West Area Health Service (Royal Prince Alfred Hospital)
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Heart Failure, run by Royal Prince Alfred Hospital, Sydney, Australia at 15 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00858039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.