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Clinical efficacy & safetyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-2 summaryPALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)SafetySafety overviewPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresIBRANCE long-term safetyGI and liver toxicitiesEffect of IBRANCE on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyRW evidenceValue of RWEWhat is real-world evidence?What is the value of RWE?P-REALITY and P-REALITY XP-REALITY OverviewP-REALITY OS and rwPFSP-REALITY X OverviewP-REALITY X OS and rwPFSIRISIRIS OverviewIRIS PFS and OSPOLARIS POLARIS OverviewPOLARIS Patient-Reported OutcomesMADELINEMADELINE OverviewMADELINE Patient CharacteristicsMADELINE Patient-Reported OutcomesPalomAGEPalomAGE OverviewRWE in Older Patients with mBCPatient-reported outcomesPALOMA-2: FACT-B scoresPALOMA-3: EORTC QLQ-C30 scoresPALOMA-3: Time to deterioration in pain symptomsDosingRecommended dosing scheduleRecommended dose modifications for AEsMonitoringOne scheduled monitoring provision ResourcesMaterials
PALOMA-2 summaryPhase III trial with the longest follow-up period in its class1

In a 2:1 randomised, double-blind, Phase III trial studying IBRANCE + letrozole vs placebo + letrozole in post-menopausal women receiving 1st-line treatment for ER+/HER2- mBC (N=666)2

IBRANCE plus letrozole demonstrated significantly longer (>2 years) mPFS in 1st line vs placebo plus letrozole, with consistent improvements across patient subgroups including those with visceral disease and those who are elderly2,3

PALOMA-2 did not meet the secondary endpoint of OS (prespecified HR=0.74)3

IBRANCE plus letrozole demonstrated significantly longer (>2 years) mPFS in 1st line vs placebo plus letrozole, with consistent improvements across patient subgroups including those with visceral disease and those who are more elderly2,3

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mPFS = median progression-free survival;  OS = overall survival; ER+/HER2- =  estrogen receptor-positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer.References:Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.Finn RS, et al. ASCO 2022; oral presentation LBA1003.
PALOMA-2 P-REALITY real-world study

Discover how patients responded to IBRANCE combination therapy in the
real-world setting

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IBRANCE Summary of Product Characteristics Product Characteristics Loading

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