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sapanisertib plus fulvestrant (n=47) vs. fulvestrant (n=46)
randomized controlled trial
sapanasertib plus fulvestrant
sapanisertib: 4 mg orally daily / fulvestrant: 500 mg intramuscularly every 28 days
fulvestrant
fulvestrant: 500 mg intramuscularly every 28 days
la/mBC - HR-positive - 2nd line (L2)
open label
50 study sites in the United States and Spain
P2 / PFS at 2-sided at 0.1 / No formal interim analysis is planned.
It seems that adding sapatinertib daily or weekly did not improve significantly PFS
sapanisertib plus fulvestrant (n=48) vs. fulvestrant (n=46)
randomized controlled trial
sapinasertib plus fulvestrant
sapanisertib: 30 mg orally weekly / fulvestrant: 500 mg intramuscularly every 28 days
fulvestrant
fulvestrant: 500 mg intramuscularly every 28 days
la/mBC - HR-positive - 2nd line (L2)
open label
50 study sites in the United States and Spain
P2 / PFS at 2-sided at 0.1 / No formal interim analysis is planned.
It seems that adding sapatinertib daily or weekly did not improve significantly PFS
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