NCT01320111

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel and Sorafenib	intravenous solution, 80 mg/sqm, 3 times per cycle, with one cycle = 28 d and application at days 1, 8 and 15 AND pills (200mg), cycle 1: 400 mg / day cycle 2: 600 mg / day from cycle 3: 800 mg / day
DRUG	Paclitaxel	intravenous solution, 80 mg/sqm, 3 times per cycle, with one cycle = 28 d and application at days 1, 8 and 15

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-08-31
• Completion: 2014-08-31
• First posted: 2011-03-22
• Last updated: 2017-02-20

Locations

1 site across 1 country: Germany