Status:
COMPLETED
CADY Study ICORG 08-01
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Breast Cancer
Cardiac Toxicity
Eligibility:
FEMALE
18+ years
Brief 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 do...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- ECOG Performance status 0, 1 or 2.
- Adequate cardiac function, with MUGA or Echocardiograph \> 50%.
- Written informed consent.
- Exclusion Criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00968682
Start Date
April 1 2008
Last Update
December 31 2014
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Bons Secours Hospital
Cork, Ireland
2
Cork University Hospital
Cork, Ireland
3
Our Ladies of Lourdes Hospital
Drogheda, Ireland
4
Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin, Ireland, 24