Northwestern University and ACORN Initiate Enrollment for Breast Cancer Study

Northwestern University has begun enrollment for a national clinical research study for women with locally recurrent or metastatic breast cancer. The Northwestern trial will evaluate the efficacy of Nexavar tablets in combination with the anticancer drug paclitaxel.

This research study is a double-blind, placebo-controlled randomized Phase IIb study that will be conducted at about 50 sites in approximately 20 states. In addition to evaluating the effectiveness of combining Nexavar (Sorafenib), and paclitaxel, the study will measure how well participants tolerate the study drug, and how a participant’s quality of life is affected.

Northwestern University is collaborating with Accelerated Community Oncology Research Network (ACORN), a contract research organization, for the trial.

Nexavar, an oral multi kinase inhibitor being co-developed by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, is currently approved for the treatment of kidney cancer.

William Gradishar, professor of medicine at the Feinberg School of Medicine of Northwestern University and the principle investigator of the study, said: “Sorafenib has demonstrated significant antitumor activity as reported in recent pivotal clinical trials. To further characterize the activity of sorafenib, this clinical trial will randomize patients with metastatic breast cancer to receive weekly paclitaxel or the combination of paclitaxel and sorafenib. This trial will determine if an oral multi-kinase inhibitor adds to the clinical benefit derived from chemotherapy alone in patients with metastatic breast cancer.”