Phase IB/II Trial Combining Vinorelbine With Sorafenib as First-Line Treatment in Patients With Metastatic Breast Cancer

Summary

This is a phase IB/II trial of sorafenib, a new tyrosine kinase inhibition of multiple genes that is active against renal cancer, plus vinorelbine, a chemotherapy agent active in breast cancer. The investigators are combining these 2 drugs in order to determine if the investigators can increase the activity of vinorelbine in metastatic breast cancer patients. Patients with measurable metastatic breast cancer without previous chemotherapy for metastatic disease are eligible for the protocol. They will be treated with 2 different dose levels of sorafenib in order to determine the most tolerable dose.

Timeline

Start

2007-10

Primary completion

2010-12

Completion

2011-12

Publications

• Ferrario C, Strepponi I, Esfahani K, Charamis H, Langleben A, Scarpi E, Nanni O, Miller WH Jr, Panasci LC. Phase I/II Trial of Sorafenib in Combination with Vinorelbine as First-Line Chemotherapy for Metastatic Breast Cancer. PLoS One. 2016 Dec 19;11(12):e0167906. doi: 10.1371/journal.pone.0167906. eCollection 2016.

Drugs

Indications