Eisai initiates Phase 3 Trial for metastatic breast cancer drug
Eisai Inc., Woodcliff Lake, NJ, announced the start of a large, randomized Phase 3 trial to compare the efficacy, safety and tolerability of eribulin mesylate to standard weekly paclitaxel as a first- or second- line treatment for HER2-negative locally recurrent or metastatic breast cancer (MBC). Recruitment is currently active for this multicenter study, conducted in partnership with the Academic and Community Cancer Research United (ACCRU) group, and aims to enroll approximately 910 patients across the U.S. The primary endpoint is overall survival.
This research study involves an investigational use of eribulin mesylate. The efficacy and safety of eribulin mesylate in first- and second-line MBC have not been established and this release is not intended to convey conclusions of efficacy and safety.
"As a human healthcare company, Eisai is committed to further exploring new treatments for metastatic breast cancer patients," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai.
About The Study
This study is for HER2-negative breast cancer patients who have received no more than one prior chemotherapy regimen once their breast cancer has spread. Eligible patients will be randomly selected with equal allocation (1:1) to receive treatment for their cancer with either eribulin mesylate or standard weekly paclitaxel, within strata defined by prior adjuvant taxanes, hormone receptor status (ER/PgR), and line of therapy.
The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival and objective tumor response rate. Safety and tolerability of the treatment groups will also be continuously monitored.
To learn more about this clinical trial, please visit www.clinicaltrials.gov/show/NCT02037529.
About Metastatic Breast Cancer
Metastatic breast cancer (MBC) is the form of the disease that refers to the most advanced stage, in which cancer cells break away from the tumor in the breast, spread to other parts of the body and continue growing. In 2013, an estimated 234,580 women will be diagnosed with breast cancer in the U.S. Approximately 30 percent of patients having an initial diagnosis of early-stage breast cancer will go on to develop recurrent, advanced or MBC.
About Eribulin Mesylate Injection
Eribulin mesylate injection (available as Halaven®) is currently indicated for patients with breast cancer who have received at least two other types of medicines for their breast cancer once it has spread. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer. Eribulin is a non-taxane, microtubule dynamics inhibitor that is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please www.eisai.com/US.
The Academic and Community Cancer Research United (ACCRU) is a clinical research group whose operations are based at the Mayo Clinic Cancer Center in Rochester, Minn. ACCRU includes a network of more than 65 academic and community-based cancer treatment clinics and hospitals in the United States and Canada. ACCRU, formerly Mayo Clinic Cancer Research Consortium (MCCRC), was established in 2004 to conduct clinical trials to improve cancer care.
HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.