OBI-822/OBI-821 plus cyclophosphamide (n=225) vs. chemotherapy (n=124)
randomized controlled trial
OBI-822/OBI-821 plus cyclophsophamide
OPT-822/OPT-821: 30 μg/100 μg at weeks 1, 2, 3, 5, 9, 13, 17, 25, and 37 for a total of nine doses or until disease progression / cyclophosphamide: IV 300 mg/m2 weeks 1, 5, 9, 13, 17, 25, and 37, 3 days prior to each dose of study drug
cyclophsophamide
cyclophosphamide: IV 300 mg/m2 weeks 1, 5, 9, 13, 17, 25, and 37, 3 days prior to each dose of study drug
la/mBC - HR-positive - 2nd line (L2)
Exclusion criteria included more than two lines of prior anticancer therapy; chemotherapy within 4 weeks of randomization; autoimmune disease or disorder requiring treatment with systemic corticosteroids or immunosuppressive therapies; any other investigational drug; any evidence or history of central nervous system metastases; and bone-only metastases.
double blind
at 40 sites in Taiwan (15), USA (12), Korea (10), India (2), and Hong Kong (1)