Breast CancerNCT00968682
CADY Study ICORG 08-01
An observational study of Breast Cancer and Cardiac Toxicity, run by Cancer Trials Ireland at 14 sites in Ireland.
Trial summary
RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may also help doctors predict which patients will develop heart dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Cardiac Toxicity
- What is being tested?
- trastuzumab, laboratory biomarker analysis and assessment of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 14 sitesIreland
- Study dates
- Apr 2008to Apr 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 diagnosed with HER2 positive breast cancer, who are foreseen for neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab. Patients enrolled on BETH or ALTTO are also eligible.
Who may be able to join
- HER-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.
- Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab.
- 18 years of age or older.
- Disease Stage I-III, whose treatment plan includes Trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.
- As this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.
- Treatment with curative intent.
Show all 9Show fewer
- ECOG Performance status 0, 1 or 2.
- Adequate cardiac function, with MUGA or Echocardiograph > 50%.
- Written informed consent.
Who cannot join
- Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
- Evidence of metastatic disease.
- Patients with uncontrolled hypertension (sustained systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.
- Prior anthracycline or Trastuzumab therapy.
- Inability to give informed consent for any reason.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Ireland14 sites
Bons Secours Hospital
Cork
Cork University Hospital
Cork
Our Ladies of Lourdes Hospital
Drogheda
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, 24
St. Vincent's University Hospital
Dublin, 4
Mater Misericordiae University Hospital
Dublin, 7
St. James's Hospital
Dublin, 8
Beaumont Hospital
Dublin, 9
Mater Private Hospital
Dublin
University College Hospital
Galway
Letterkenny General Hospital
Letterkenny
Mid- Western Regional Hospital
Limerick
Sligo General Hospital
Sligo
Waterford Regional Hospital
Waterford
About this study
Official title: Detection of Cardiac Dysfunction in Patients Treated With Trastuzumab for HER-2 Positive Breast Cancer. The CADY Study
RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may also help doctors predict which patients will develop heart dysfunction.
PURPOSE: This clinical trial is studying biomarkers to see how well they predict heart dysfunction in women with breast cancer treated with trastuzumab.
Read the detailed description
OBJECTIVES:
Primary
- To prospectively evaluate whether an increase in cardiac biomarker levels can predict cardiac dysfunction in women with HER2/neu-positive breast cancer treated with trastuzumab as curative intent.
Secondary
- To develop a predictive model for use in this patient population based on the most accurate and sensitive combination of biomarkers.
This is an observational study with all patients having
- Blood tests for BNP, Nt-pro BNP, CRP and Troponin-T every 42 days (6 weeks) whilst on treatment with chemotherapy and/or Trastuzumab.
- Echocardiograph or MUGA before treatment, after completion of anthracycline therapy where applicable, and every twelve weeks whilst on Trastuzumab. Assessment of ejection fraction may be carried out at any time for symptoms. All Echocardiographs and MUGAs will be carried out locally. 2-D Echocardiograph is the preferred method for assessment of LVEF. Where possible, the same cardiac imaging facility should be used for all LVEF assessments. A sample study from each participating institution will be reviewed by the principal investigating cardiologist. Results of left ventricular function assessment will be used to make treatment decisions as normal. Managing clinicians will not be made aware of the results of biomarker assessments, thus this study is blinded.
- Cardiorespiratory symptom assessment, ECOG score, vitals, weight and NYHA (if applicable) prior to each dose of anthracyclines and every 6 weeks whilst on Paclitaxel-trastuzumab and on single agent Trastuzumab.
Patients on BETH :
The LVEF monitoring sequence required by CADY will be altered to parallel that required by BETH. Thus, echocardiograph or MUGA will be carried out according to the BETH cardiac safety monitoring protocol. This altered schedule applies only to patients enrolled in both studies. Of note, for patients on the BETH study, all LVEF assessments must be performed by the same method used at baseline.
Patients on ALTTO:
It is possible that a patient who is enrolled on both CADY and ALLTO may not eventually receive Trastuzumab. Nonetheless, as Lapatinib is also associated with a risk of cardiotoxicity, such patients should remain on study whilst receiving single agent Lapatinib. The schedule of on study assessments will be identical to that of patients receiving Trastuzumab.
For patients enrolled in both studies, the LVEF monitoring sequence required by CADY will be altered to parallel that required by ALLTO. Thus, echocardiograph or MUGA will be carried out according to the ALLTO cardiac safety monitoring protocol Of note, for patients on the ALLTO study, all LVEF assessments must be performed by the same method used at baseline.
- Conditions
- Breast Cancer, Cardiac Toxicity
- Being tested
- trastuzumab, laboratory biomarker analysis, assessment of therapy complications
- Keywords
- cardiac toxicity, HER2-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
laboratory biomarker analysisOther
assessment of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac biomarker levels in predicting cardiac dysfunction
Measured: End of trial
Development of a predictive model for use based on the most accurate and sensitive combination of biomarkers
Measured: End of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ray McDermott, MD, Principal investigator, Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968682
- Sponsor's protocol ID
- 08-01 ICORG
- Other IDs
- ICORG-08-01, EU-20948
- Status last verified
- Aug 2014
- First submitted
- 28 Aug 2009
- Last updated
- 31 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Cardiac Dysfunction in Patients Treated With Trastuzumab for HER-2 Positive Breast Cancer. The CADY Study
- ClinicalTrials.gov ID
- NCT00968682
- Acronym / sponsor ID
- 08-01 ICORG
- Conditions
- Breast Cancer, Cardiac Toxicity
- Keywords
- cardiac toxicity, HER2-positive breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Apr 2008
- Primary completion
- Apr 2014 (actual)
- First posted
- 31 Aug 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.
RATIONALE: Studying samples of blood in the laboratory from patients with cancer treated with trastuzumab may help doctors learn more about biomarkers related to heart dysfunction. It may also help doctors predict which patients will develop heart dysfunction.
PURPOSE: This clinical trial is studying biomarkers to see how well they predict heart dysfunction in women with breast cancer treated with trastuzumab.
Detailed description
OBJECTIVES:
Primary
- To prospectively evaluate whether an increase in cardiac biomarker levels can predict cardiac dysfunction in women with HER2/neu-positive breast cancer treated with trastuzumab as curative intent.
Secondary
- To develop a predictive model for use in this patient population based on the most accurate and sensitive combination of biomarkers.
This is an observational study with all patients having
- Blood tests for BNP, Nt-pro BNP, CRP and Troponin-T every 42 days (6 weeks) whilst on treatment with chemotherapy and/or Trastuzumab.
- Echocardiograph or MUGA before treatment, after completion of anthracycline therapy where applicable, and every twelve weeks whilst on Trastuzumab. Assessment of ejection fraction may be carried out at any time for symptoms. All Echocardiographs and MUGAs will be carried out locally. 2-D Echocardiograph is the preferred method for assessment of LVEF. Where possible, the same cardiac imaging facility should be used for all LVEF assessments. A sample study from each participating institution will be reviewed by the principal investigating cardiologist. Results of left ventricular function assessment will be used to make treatment decisions as normal. Managing clinicians will not be made aware of the results of biomarker assessments, thus this study is blinded.
- Cardiorespiratory symptom assessment, ECOG score, vitals, weight and NYHA (if applicable) prior to each dose of anthracyclines and every 6 weeks whilst on Paclitaxel-trastuzumab and on single agent Trastuzumab.
Patients on BETH :
The LVEF monitoring sequence required by CADY will be altered to parallel that required by BETH. Thus, echocardiograph or MUGA will be carried out according to the BETH cardiac safety monitoring protocol. This altered schedule applies only to patients enrolled in both studies. Of note, for patients on the BETH study, all LVEF assessments must be performed by the same method used at baseline.
Patients on ALTTO:
It is possible that a patient who is enrolled on both CADY and ALLTO may not eventually receive Trastuzumab. Nonetheless, as Lapatinib is also associated with a risk of cardiotoxicity, such patients should remain on study whilst receiving single agent Lapatinib. The schedule of on study assessments will be identical to that of patients receiving Trastuzumab.
For patients enrolled in both studies, the LVEF monitoring sequence required by CADY will be altered to parallel that required by ALLTO. Thus, echocardiograph or MUGA will be carried out according to the ALLTO cardiac safety monitoring protocol Of note, for patients on the ALLTO study, all LVEF assessments must be performed by the same method used at baseline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with HER2 positive breast cancer, who are foreseen for neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab. Patients enrolled on BETH or ALTTO are also eligible.
Key inclusion criteria (9 listed)
- HER-2 positive breast cancer by immunohistochemistry and/or fluorescence in-situ hybridisation.
- Planned neoadjuvant and/or adjuvant treatment with chemotherapy and Trastuzumab either sequentially or in combination or single agent Trastuzumab.
- 18 years of age or older.
- Disease Stage I-III, whose treatment plan includes Trastuzumab either sequentially, in combination or as a single agent will be eligible for inclusion in the study.
- As this is a non-interventional study, patients enrolled in therapeutic clinical trials will also be eligible for inclusion.
Key exclusion criteria (5 listed)
- Presence of a medical or psychiatric condition, which, in the opinion of the investigator, would potentially pose a risk to the patient by participating in this trial.
- Evidence of metastatic disease.
- Patients with uncontrolled hypertension (sustained systolic blood pressure >180mmHg or diastolic blood pressure >100mmHg), significant valvular disease (aortic or mitral regurgitation of 3 or 4+/ 4+ severity or stenosis of either valve), history of uncontrolled cardiac arrhythmias, prior symptomatic or asymptomatic myocardial infarction or angina pectoris requiring anti-anginal medication.
- Prior anthracycline or Trastuzumab therapy.
- Inability to give informed consent for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumab | Biological | – |
| laboratory biomarker analysis | Other | – |
| assessment of therapy complications | Procedure or surgery | – |
Primary outcome
Cardiac biomarker levels in predicting cardiac dysfunction
Time frame: End of trial
Development of a predictive model for use based on the most accurate and sensitive combination of biomarkers
Time frame: End of trial
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 31 Dec 2014.
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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.
Ray McDermott, MD principal investigator
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
14 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 Cancer and Cardiac Toxicity, run by Cancer Trials Ireland at 14 sites in Ireland.
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 9 inclusion and 5 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 31 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Ireland. 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?
Cardiac biomarker levels in predicting cardiac dysfunction (time frame: End of trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2014.