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
ribociclib plus fulvestrant
MONALEESA-3, 2018
  NCT02422615
RCTla/mBC - HR-positive - 2nd line (L2)ribociclib plus fulvestrantplacebo plus fulvestrantPostmenopausal women and men with confirmed HR-positive and HER2-negative advanced/metastatic breast cancer484 / 242low
conclusif
  • demonstrated 28 % decrease in deaths (OS) (PE)
  • demonstrated 41 % decrease in progression or deaths (PFS) (PE)
  • suggested 27 % decrease in deaths (OS) (extension)