Caelyx Adjuvant in Elderly Breast Cancer
This is an open label Phase II study in elderly patients (65y or older) with early breast cancer who are candidate for adjuvant chemotherapy. A scheme with liposomal doxorubicin (Caelyx) and cyclophosphamide (endoxan) will be used. The aim is to study the cardiac effects of liposomal doxorubicin with new non-invasive techniques, ie strain rate imaging, classical echocardiography, and special blood tests measuring troponin I and BNP.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Phase II Trial to Investigate the Cardiac Effects of Pegylated Liposomal Doxorubicine (Caelyx) in Elderly Breast Cancer Patients With New Imaging and Biochemical Techniques.|
- Investigate the effect on cardiac strain rate imaging (SRI) of Caelyx
- The relation between cardiac SRI and classical ejection fraction measurement.
- The relation between strain rate and blood markers such as troponin-I and BNP
- To assess the tolerability of Caelyx containing regimens in elderly breast cancer patients.
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||April 2007|
|Gent, Belgium, 9000|
|Leuven, Belgium, 3000|
|Principal Investigator:||hans wildiers, MD PhD||UH gasthuisberg Leuven|