Study study type PathologyT1T0Patientssample sizesROB Results deaths (OS) Eprogression or deaths (PFS) ERFS/DFS E

la/mBC - HR-positive - 1st line (L1) breast cancer - HR positive la/mBC - HR positive la/mBC - HR-positive - 1st line (L1)

versus aromatase inhibitor
abemaciclib plus aromatase inhibitor
MONARCH 3, 2017
  NCT02246621
RCTla/mBC - HR-positive - 1st line (L1)abemaciclib plus a nonsteroidal aromatase inhibitorplacebo plus a nonsteroidal aromatase inhibitorPostmenopausal women (aged 18 or more)with locally advanced HR-positive, HER2-negative locoregionally recurrent BC328 / 165low
conclusif demonstrated-46%
versus endocrine therapy
abemaciclib plus endocrine therapy
MonarchE, 2021
  NCT03155997
RCTla/mBC - HR-positive - 1st line (L1)abemaciclib plus endocrine therapyendocrine therapyPatients (women and men) with HR-positive and HER2-negative breast cancer. Radiotherapy and both adjuvant and neoadjuvant chemotherapy were allowed, but not required.2808 / 2829high
conclusif

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

versus fulvestrant
abemaciclib plus fulvestrant
MONARCH 2, 2020
  NCT02107703
RCTla/mBC - HR-positive - 2nd line (L2)abemaciclib plus fulvestrantplacebo plus fulvestrantWomen with HR-positive and HER2-negative advanced breast (ABC) cancer who progressed during neoadjuvant or adjuvantendocrine therapy (ET), within 12months after adjuvant ET, or while receiving first line ET for ABC446 / 223low
conclusif demonstrated-24% demonstrated-45%