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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for the UK. IBRANCE® (palbociclib) Prescribing Information for the UK click here. Adverse event reporting information can be found at the bottom of the page.
PALOMA-3 was a Phase III trial that assessed the efficacy and safety of IBRANCE (palbociclib) plus fulvestrant (n=347) versus placebo plus fulvestrant (n=174) in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced and metastatic breast cancer that progressed on previous endocrine therapy.2,3,4
The study primary endpoint was investigator-assessed (IA) progression-free survival (PFS), and the key secondary endpoint was overall survival (OS).2,3,4
Adapted from Cristofanilli M, et al. Eur J Cancer. 2018.3
*Data cut-off date: 23rd October 2015. Median follow-up of 14.0 months (95% CI: 13.9–14.5) in the IBRANCE plus fulvestrant arm;2 †Investigator-assessed PFS was defined as the time from date of randomisation to the date of first documented objective disease progression (per RECIST v1.1) or death due to any cause, whichever occurred first.2
Adapted from Turner NC, et al. NEJM 2018.4
*Data cut-off date: 13th April 2018. Median follow-up of 44.8 months and 60% data maturity (310 deaths among 521 patients);4 †OS was defined as time from randomisation to death from any cause.4
Click here to learn more about the PALOMA-3 Trial - including study design, further efficacy outcomes and safety information.
AI, aromatase inhibitor; CI, confidence interval; ER, endocrine receptor; HER2, human epidermal growth factor 2; HR, hazard ratio; HR+, hormone receptor-positive; ITT, intention-to-treat; IA, investigator assessed; LHRH, luteinising hormone-releasing hormone; NE, not estimable; OS, overall survival; PFS, progression-free survival; RECIST, response evaluation criteria in solid tumours
References
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