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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 mBCP-VERIFYP-VERIFY StudyPatient-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 provisionPrescribing Information ResourcesMaterials
MADELINE patient-reported outcomesDaily PROs collected suggested a low level of pain and fatigue that did not change substantially over time regardless of experience with neutropenia1

Cycles were based solely on completion of mobile application entries.
Adapted from Richardson D, et al. 2021.1

Patients reported consistent general health status, low depression and stable overall health regardless of experience with neutropenia

Cycles were based solely on completion of mobile application entries.
Adapted from Richardson D, et al. 2021.1

• SF-12 PCS/MCS showed no association between neutropenia and QoL

 Observational prospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational prospective analyses are not intended for direct comparison with clinical trials.2,3 Explore More PalomAGE overview Explore more Loading POLARIS PROs Explore more LoadingCES-D-10 = 10-Item Center for Epidemiological Studies Depression Scale; MCS = mental component summary; 
PCS = physical component summary; PRO = patient-reported outcome; QoL = quality of life; SD = standard deviation; SF-12 = 12-item Short Form Health Survey.References:Richardson D, et al. Breast Cancer Res Treat. 2021;187:113-124.Gerstein HC, et al. Lancet. 2019;393:210-211.Corrigan-Curay J, et al. JAMA. 2018;320:867-868.MADELINE
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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