Study study type PathologyT1T0Patientssample sizesROB Results

la/mBC - HR positive breast cancer - HR positive la/mBC - HR positive

versus capecitabine
palbociclib plus endocrine therapy
KCSG-BR15-10, 2019
  NCT02592746
RCTla/mBC - HR positivepalbociclib plus exemestanecapecitabinePremenopausal women aged 19 years or older with histologically confirmed, hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer were eligible.92 / 86NA
suggested
  • suggested 34 % decrease in progression or deaths (PFS) (PE)

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 % decrease in progression or deaths (PFS) (PE)
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 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)
versus letrozole
palbociclib plus letrozole
PALOMA-1, 2016
  NCT00721409
RCTla/mBC - HR-positive - 1st line (L1)palbociclib plus letrozoleletrozolePostmenopausal women with ER-positive and HER2-negative advanced breast cancer. Enrolled in 2 separate cohorts (cohort 1: ER-positive and HER2-negative / cohort 2: they were also required to have cancers with amplification of cyclin D1 (CCND1), loss of p16 (also known as INK4A or CDKN2A), or both)84 / 81high
suggested
  • suggested 51 % decrease in progression or deaths (PFS) (PE)
PALOMA-2, 2016
  NCT01740427
RCTla/mBC - HR-positive - 1st line (L1)palbociclib plus letrozoleplacebo plus letrozolePostmenopausal women with ER-positive, HER2-negative advanced breast cancer were eligible for enrollment if they had not received prior systemic therapy for advanced disease.444 / 222NA
conclusif
  • demonstrated 42 % decrease in progression or deaths (PFS) (PE)
  • suggested 44 % decrease in PFS (extension)
ribociclib plus letrozole
MONALEESA-2, 2016
  NCT01958021
RCTla/mBC - HR-positive - 1st line (L1)ribociclib plus letrozoleplacebo plus letrozolePostmenauposal women with locally confirmed HR-positive, HER2-negative recurrent or metastatic BC who had not received previous systematic therapy for advanced disease334 / 334low
conclusif
  • demonstrated 24 % decrease in deaths (OS) (PE)
  • demonstrated 44 % decrease in progression or deaths (PFS) (PE)

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

versus endocrine therapy
ribociclib plus endocrine therapy
MONALEESA-7, 2018
  NCT02278120
RCTla/mBC - HR-positive - 2nd line (L2)ribociclib plus endocrine therapy plus goserelinplacebo plus endocrine therapy plus goserelinWomen premenopausal or perimenopausal at the time of entry, with histologically or cytologically confirmed HR-positive and HER2-negative breast cancer.335 / 337low
conclusif
  • demonstrated 45 % decrease in progression or deaths (PFS) (PE)
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 % decrease in deaths (OS) (PE)
  • demonstrated 45 % decrease in progression or deaths (PFS) (PE)
dalpiciclib plus fulvestrant
DAWNA-1, 2021
  NCT03927456
RCTla/mBC - HR-positive - 2nd line (L2)dalpiciclib plus fulvetrantplacebo (matching dulpaciclib) plus fulvestrantWomen aged of 18-75yr with pathologically confirmed HR-positive and HER2-negative locally advanced or metastatic BC. Nor more than 1 previous chemotherapy for advanced disease.241 / 120low
conclusif
  • demonstrated 58 % decrease in progression or deaths (PFS) (PE)
palbociclib plus fulvestrant
FLIPPER, 2021
  NCT02690480
RCTla/mBC - HR-positive - 2nd line (L2)palbociclib plus fulvestrantplacebo plus fulvestrantPostmenauposal women with HR-positive and HER-negative advanced breast cancer94 / 95low
suggested
  • suggested 45 % decrease in progression or deaths (PFS) (PE)
PALOMA-3, 2016
  NCT01942135
RCTla/mBC - HR-positive - 2nd line (L2)palbociclib plus fulvestrantplacebo plus fulvestrantEligible patients were pre- or post menopausal with breast cancer and histologic or cytologicconfirmation of recurrent local or distant disease progression during or within 12 months of completion of adjuvant endocrinetherapy or while receiving or within 1 month after receivingendocrine therapy for MBC347 / 174low
conclusif
  • inconclusive 19 % decrease in deaths (OS) (PE)
  • demonstrated 58 % decrease in progression or deaths (PFS) (PE)
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)