The purpose of this study is to determine the efficacy and safety of sorafenib in the neoadjuvant setting in patients with primary breast cancer
Epirubicin/Cyclophosphamide followed by Paclitaxel (EC/P) is a well tolerated regimen with high clinical activity. Histopathological complete remission after preoperative chemotherapy has a direct correlation with the disease-free and overall survival. The aim of combining a chemotherapy regime with sorafenib in the neoadjuvant setting is to increase the locoregional and systemic outcome of these patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Tablet, Sorafenib follows a patient specific escalation scheme starting with 200 mg daily up to a maximum dose of 800 mg daily during EC chemotherapy on day 2-19. The achieved dose will be continued during paclitaxel chemotherapy during week 1-11 all day
St. Gertrauden Krankenhaus
Berlin, Germany
Klinikum der Universität zu Köln
Cologne, Germany
Klinikum der J. W. Goethe Universität
Frankfurt am Main, Germany
Henriettenstiftung
Hanover, Germany
to establish the most feasible regimen of EC-P (P-EC) with sorafenib
Time frame: Time of surgery
Safety of preoperative regimen
Time frame: Treatment to Surgery
Determine clinical response rate
Time frame: Time of surgery
Histopathological axillary nodal status after neoadjuvant therapy
Time frame: Time of surgery
Correlate baseline and change in tumor and serum genetic, gene expression and proteomic patterns with clinical and pathological response
Time frame: Baeline till time of surgery
pCR rate at surgery
Time frame: Treatment ot Surgery
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Elisabeth Krankenhaus
Kassel, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany
Klinikum Offenbach
Offenbach, Germany
Klinikum Südstadt
Rostock, Germany
Dr.-Horst-Schmidt-Kliniken GmbH
Wiesbaden, Germany