Study study type PathologyT1T0Patientssample sizesROB Results

breast cancer - adjuvant breast cancer - adjuvant

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
  • demonstrated 25 % decrease in iDFS (PE)
palbociclib
PALLAS, 2022
  NCT02513394
RCTbreast cancer - adjuvantPatients with histollogically confirmed stage II or III HR-positive BC. Before random assignment, patients had completed definitive breast surgery (and (neo)adjuvantchemotherapy and/or radiotherapy, if indicated)2884 / 2877NA
inconclusive
    no statistically significant result
palbociclib plus endocrine therapy
PENELOPE-B, 2021
  NCT01864746
RCTla/mBC - HR-positive - 1st line (L1)palbociclib plus endocrine therapy according to local standars (physician's choice)placebo plus endocrine therapy according to local standars (physician's choice)Women with residual invasive disease after NACT (NACT during at least 16 weeks) in the breats or in lymph nodes, ER and/or PR positive and HER2 negative tumor.628 / 616low
inconclusive
  • inconclusive 7 % decrease in iDFS (PE)