Randomised Phase II Study of Paclitaxel Alone Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment of Patients With Metastatic Breast Cancer
Today breast carcinoma is the leading cancer type and the second frequent cause of cancer
death in adult women. This tumor remains a challenge in modern oncology despite recent
advances by introducing new classes of chemotherapy like taxanes and antibodies for the
HER-2/neu positive tumors. Recently it was shown that the combination of conventional
chemotherapy with a monoclonal antibody against VEGF can further increase the response and
progression free survival by combination with an antiangiogenic therapy. It is supposed that
this effect might result in a prolonged survival.
Sorafenib, a new developed oral inhibitor for tyrosine kinases which are responsible for the
signal transduction after binding to the VEGF receptor and the RAS-Raf-MEK-ERK pathway seems
efficient in the treatment of a broad range of tumors.
The multi-kinase inhibitor Sorafenib targets the Raf/MEK/ERK pathway at the level of Raf
kinase and the receptor tyrosine kinases VEGFR-2 and PDGFR-β, thereby affecting both, the
tumour and the vasculature. Preclinical studies as well as phase I trials showed anti-tumour
activity in patients with metastatic breast cancer treated with single-agent sorafenib.
This multicentre, phase II, open-label, randomised study is designed to assess the potential
prolongation in progression free survival in patients with metastatic breast cancer in
combination with standard chemotherapy paclitaxel compared with the paclitaxel monotherapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival (PFS)
The primary study objective is the proof of efficacy, measured by progression free survival (PFS) in the treatment of metastatic or locally inoperable recurrent breast cancer. Progression-free survival (PFS) is defined as the time from randomisation to disease progression or death.
app. 3 yrs
Yes
Friedrich Overkamp, Dr. med.
Principal Investigator
Germany: Federal Institute for Drugs and Medical Devices
GMIHO-008/2008
NCT01320111
July 2010
August 2014
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