To compare the pathological complete response (pCR=ypT0 ypN0) rates of neoadjuvant treatment of nab-paclitaxel with solvent-based paclitaxel as part of neoadjuvant treatment of operable or locally advanced primary breast cancer.
Introduction
A randomized phase III trial comparing nanoparticle-based Paclitaxel with solvent-based Paclitaxel as part of neoadjuvant chemotherapy for patients with early breast cancer (GeparSepto).
News
Study reopened for a non-interventional follow-up phase
Design
Multicenter, prospective, randomized, open phase III study
Patients will be randomized to one of the following arms according to a 2-arm study design:
- Arm A: Paclitaxel 80 mg/m2 weekly (12 weeks) followed by 12 weeks Epirubicin 90 mg/m2 and Cyclophosphamide 600 mg/m2
- Arm B: nab-Paclitaxel 125 mg/m2 weekly (12 weeks) followed by 12 weeks Epirubicin 90 mg/m2 and Cyclophosphamide 600 mg/m2
Patients with HER2-positive disease will receive simultaneously in all cycles Trastuzumab 8 mg/kg (loading dose) followed by 6 mg/kg and Pertuzumab 840 mg (loading dose) followed by 420 mg every 3 weeks.
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.
