CADY Study ICORG 08-01
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.
Other: laboratory biomarker analysis
Procedure: assessment of therapy complications
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Detection of Cardiac Dysfunction in Patients Treated With Trastuzumab for HER-2 Positive Breast Cancer. The CADY Study|
- 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 ]
|Study Start Date:||April 2008|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968682
|Bons Secours Hospital|
|Cork University Hospital|
|Our Ladies of Lourdes Hospital|
|Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|
|Dublin, Ireland, 24|
|St. Vincent's University Hospital|
|Dublin, Ireland, 4|
|Mater Misericordiae University Hospital|
|Dublin, Ireland, 7|
|St. James's Hospital|
|Dublin, Ireland, 8|
|Dublin, Ireland, 9|
|Mater Private Hospital|
|University College Hospital|
|Letterkenny General Hospital|
|Mid- Western Regional Hospital|
|Sligo General Hospital|
|Waterford Regional Hospital|
|Principal Investigator:||Ray McDermott, MD||Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital|