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 endocrine therapy
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)

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

versus fulvestrant
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)

 

- About us - Contact us - Method - RSS Made with in Lyon - Credits - Privacy policy - Licence Creative Commons