BioCentury
ARTICLE | Clinical News

Adaptive breast cancer trial launched

March 18, 2010 1:01 AM UTC

A consortium of public health agencies, academic researchers and pharmaceutical companies launched a screening program on Wednesday that is designed to rapidly and inexpensively develop data to support small Phase III trials of new therapies for locally advanced breast cancer -- or help companies quickly kill ineffective drug candidates. The Biomarkers Consortium, a public-private partnership that includes FDA, NIH and pharmaceutical companies, is managing the I-SPY 2 trial. The study will initially test five compounds in the neoadjuvant setting: veliparib (ABT-888) from Abbott Laboratories (NYSE:ABT); conatumumab (AMG 655) and AMG 386 from Amgen Inc. (NASDAQ:AMGN); and figitumumab and neratinib (HKI-272) from Pfizer Inc. (NYSE:PFE). Compounds will be tested on 20-120 patients. After a compound has been "graduated" as being ready for Phase III testing by the sponsor, or dropped for futility, additional compounds may be added to the trial. All data from I-SPY 2 will be placed in the public domain. ...