Study study type PathologyT1T0Patientssample sizesROB Results

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

versus fulvestrant
buparlisib plus fulvestrant
BELLE-3, 2018
  NCT01633060
RCTla/mBC - HR-positive - 2nd line (L2)buparlisib plus fulvestrantplacebo plus fulvestrantPostmenopausal women (aged >= 18yr) with HR-positive, HER2-negative, locally advanced or metastatic breast cancer pretreated with aromatase inhibitors and resistant to endocrine therapy for advanced BC.289 / 143NA
conclusif
  • demonstrated 33 % decrease in progression or deaths (PFS) (PE)

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)

la/mBC - HR positive - L2 - PIK3CA mutant breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 2nd line (L2) la/mBC - HR positive - L2 - PIK3CA mutant

versus fulvestrant
buparlisib plus fulvestrant
BELLE-2 (PI3K pathway activated), 2017
  NCT01610284
RCTla/mBC - HR positive - L2 - PIK3CA mutantbuparlisib 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). This subgroup population included only patients with PI3K pathway activated188 / 184low
suggested
  • suggested 24 % decrease in progression or deaths (PFS) (PE)