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Tesaro, Breast International Group (BIG), European Network of Gynecological Oncological Trial Groups (ENGOT), European Organization for Research and Treatment o

June 10, 2013 7:00 AM UTC

Tesaro partnered with the three not-for-profits to conduct two separate Phase III cancer trials of niraparib. Under its deal with BIG and EORTC, the partners will conduct a trial of niraparib in breast cancer patients. The international trial, expected to start next half, will enroll about 300 patients previously treated with an anthracycline and a taxane with advanced or metastatic breast cancer carrying breast cancer 1 early onset (BRCA1) or BRCA2 mutations.

Tesaro also partnered with ENGOT to facilitate a trial of niraparib in ovarian cancer patients. The double-blind, placebo-controlled, international Phase III trial is expected to start mid-year and will enroll about 360 patients with platinum-sensitive, relapsed ovarian cancer. Tesaro said major goals of the partnership include optimizing protocol design, streamlining investigator selection and expediting patient enrollment and data publication from the trial. ...