Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - HR positive - L2 - all population breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2) la/mBC - HR positive - L2 - all population

versus fulvestrant
buparlisib plus fulvestrant
BELLE-2 (full population), 2017
  NCT01610284
RCTla/mBC - HR positive - L2 - all populationbuparlisib plus fulvestrantplacebo plus fulvestrantPostmenopausal women (>=18yr), with histollogically confirmed HR-positive and HER2-negative inoperable locally advanced or metastatic breast cancer (with progession on or after aromatase ihnibitor treatment)576 / 571low
conclusif
  • inconclusive 13 % decrease in deaths (OS) (PE)
  • demonstrated 22 % decrease in progression or deaths (PFS) (PE)
versus pegylated liposomal doxorubicin and cyclophosphamide
nivolumab plus ipilimumab, pegylated liposomal doxorubicin and cyclophosphamide
ICON, 2024
  NCT03409198
RCTla/mBC - HR positive - L2 - all populationIpilimumab plus nivolumab plus PLD plus cyclophosphamidePLD plus cyclophosphamidePatients with HR mBC starting first-/second- line chemotherapy (chemo)49 / 33some concern
inconclusive
  • inconclusive 6 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
The addition of ipi/nivo to chemotherapy increased toxicity without improving efficacy. Ipi/nivo administered sequentially to chemotherapy was tolerable and induced clinical responses.