Early Detection of Chemotherapy Induced Cardiac Damage in Elderly Patients With Early Breast Cancer: a Randomized Phase II Trial Comparing (Neo) Adjuvant Epirubicin-cyclophosphamide (EC) Versus Docetaxel (Taxotere)-Cyclophosphamide (TC.)
Considering that both anthracycline-based and Taxotere-cyclophosphamide CT have established
efficacy in the adjuvant treatment of elderly patients with early breast cancer, and the
paucity of data for early cardiac toxicities with anthracycline-based adjuvant therapy
compared to non-anthracycline regimen, this is the first randomized study to evaluate early
cardiac signs based on doppler myocardial imaging (DMI). The results of this study could
improve the monitoring of the cardiac function of elderly patients candidates to receive
adjuvant chemotherapy for early breast cancer.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The difference between cardiac strain rates measured at baseline and after 4 cycles of chemotherapy.
The primary null hypothesis is that the means are equal versus the alternative hypothesis that the means are different. We plan to perform the comparison using a two-sided Student's t-test with α=5%. The power of the study to detect the difference described below has been set at 90%. One hundred twenty patients candidate to receive neoadjuvant or adjuvant CT for early BC will be randomized 1:1 to receive either epirubicin-cyclophosphamide (EC) or docetaxel (Taxotere) -cyclophosphamide (TC) for 4 cycles.
Before chemotherapy, after chemotherapy, at 6 months, one , two and 3 years from randomization.
Lissandra Dal Lago, MD
Jules Bordet Institute
Belgium: Ethics Committee