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Paclitaxel

Albumin-Bound Paclitaxel

Sorafenib

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

patient is treated with 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

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

Friedrich Overkamp, Dr. med.

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

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.

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

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.

* Clinical benefit (CR+PR+SD)
* ORR (CR+PR)
* Time to progression
* Time to next Treatment (TTT)
* Overall survival
* Safety profile

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment	NCT01320111	Metastatic Brea...	Paclitaxel and ... Paclitaxel	18 Years -	Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Breast Cancer Study: Paclitaxel Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment	NCT01320111	Metastatic Brea...	Paclitaxel and ... Paclitaxel	18 Years -	Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Spots Global Cancer Trial Database for paclitaxel and sorafenib