Spots Global Cancer Trial Database for Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment

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Trial Identification

Brief Title: Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment

Official Title: Randomised Phase II Study of Paclitaxel Alone Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment of Patients With Metastatic Breast Cancer

Study ID: NCT01320111

Conditions

Metastatic Breast Cancer

Interventions

Paclitaxel and Sorafenib

Paclitaxel

Study Description

Brief Summary: AIM OF STUDY Primary Efficacy Variable: 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. Secondary Efficacy Variables: * Clinical benefit (CR+PR+SD) * ORR (CR+PR) * Time to progression * Time to next Treatment (TTT) * Overall survival * Safety profile

Detailed Description: 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.