A randomized phase III trial comparing two dose-dense, dose-intensified approaches (ETC and PM(Cb)) for neoadjuvant treatment of patients with high-risk early breast cancer.
A randomized phase III trial comparing two dose dense, dose intensified approaches (ETC and PM(Cb)) for neoadjuvant treatment of patients with high risk early breast cancer.
News
Status: Study is in Follow Up
Design
This is a multicenter, prospective, randomized, open-label phase III study with two different dose-intensified approaches as neoadjuvant therapy in patients with untreated high-risk early breast cancer.
Patients will be randomized to one of the following two treatments:
ETC treatment arm:
- epirubicin 150mg/m² every 2 weeks for 3 cycles followed by
- paclitaxel 225 mg/m² every 2 weeks for 3 cycles followed
- cyclophosphamide 2000 mg/m² every 2 weeks for 3 cycles.
or
PM(Cb):
- paclitaxel 80mg/m² 18 times weekly simultaneously with
- NPLD (Myocet®)20mg/m² 18 times weekly simultaneously with
- carboplatin AUC 1.5 18 times weekly (only in patients with TNBC)
The inclusion and exclusion criteria, as well as more detailed information on the study design, can be found in the short protocol on the list of documents.
Contact
Konstantin Reißmüller
