Northwestern University And ACORN Commence National Enrollment For Metastatic Breast Cancer Study

Main Category: Breast Cancer
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 13 Nov 2007 - 0:00 PDT

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Northwestern University announced that it 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(R) (sorafenib) tablets in combination with the anticancer drug paclitaxel for metastatic breast cancer. 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.

Northwestern University is collaborating with Accelerated Community Oncology Research Network (ACORN), the Contract Research Organization (CRO) for the trial. The University, primarily through the Feinberg School of Medicine, is part of the McGaw Medical Center of Northwestern University. The McGaw Medical Center is a consortium of urban, suburban, specialized, and general hospitals and the University. Chartered in 1966 and honoring the generosity of the late Foster G. and Mary McGaw, the center presents a greater range of clinical and research experiences than individual teaching hospitals are able to provide.

This research study is a double-blind, placebo-controlled randomized phase 2b study that will be conducted at about 50 sites in approximately 20 states. In addition to evaluating the effectiveness of combining the Nexavar and paclitaxel, the study will measure how well participants tolerate the study drug, and how a participant's quality of life is affected.

Dr. William Gradishar, professor of medicine at the Feinberg School of Medicine of Northwestern University, is the principle investigator of the study. "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."

Dr. Lee Schwartzberg directs all clinical research initiatives and provides clinical oversight and management of ACORN. "Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals and ACORN seek to advance the standards of cancer care by making the most promising molecules available to the broadest demographic population possible. ACORN's network of community oncology practices along with its centralized clinical trial management services helps make that goal possible," remarked Dr. Schwartzberg.

In addition to this clinical trial, researchers are studying Nexavar in pivotal trials in hepatocellular cancer, metastatic melanoma and non-small cell lung cancer.

Northwestern University

Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment that transcends traditional academic boundaries. It provides students and faculty exceptional opportunities for intellectual, personal, and professional growth in a setting enhanced by the richness of Chicago. Northwestern is recognized both nationally and internationally for the quality of its educational programs at all levels.

Accelerated Community Oncology Research Network, Inc. (ACORN)

The mission of ACORN is to significantly enhance the speed, accuracy, and productivity of conducting clinical research in the community oncology setting. The ACORN Contract Research Organization (CRO) enrolls research sites, provides contract and budgeting services, fosters the accrual of subjects at the site level, collects data and monitors its accuracy, and works seamlessly as an extension of both the sponsoring organization and the participating research sites.

Accelerated Community Oncology Research Network
http://www.ACORNresearch.net