Early Cardiac Toxicity of Adjuvant CT in Elderly BC.
Status:
Terminated
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
The primary objective is to evaluate the difference in cardiac strain rate evolution in
elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy
compared with a non-anthracycline regimen (Taxotere-cyclophosphamide) CT.
This study also will compare the serum biomarkers profile during and after the (neo) adjuvant
CT in both treatment arms, assess whether MRI allows detecting earlier than standard
echocardiography the signs of cardiotoxicity, during and after adjuvant (neo) CT, assess
whether brain PET-CT allows detecting regional functional impairment in patients receiving
CT, evaluate cognitive function before and after (neo) adjuvant CT in both treatment arms,
evaluate distress and functional autonomy before and after (neo) adjuvant CT in both
treatment arms, evaluate psychological state and burden of primary caregivers before and
after (neo) adjuvant CT in both treatment arms, evaluate primary caregivers abilities to
detect patients' distress and functional autonomy before and after (neo) adjuvant CT in both
treatment arms, evaluate the short and long-term toxicity profile of the regimens, estimate
the 10-year risk of relapse and/or death using the Adjuvant!Online tool, and estimate the
Framingham risk score for Hard Coronary Heart Disease (10-year risk).