Study study type
PathologyT1T0Patientssample sizesROB Results

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

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)

 

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