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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 ARsPooled 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
POLARIS overview

POLARIS (PalbOciLib in HR+ Advanced Breast Cancer – a Multicenter, Prospective, NonInterventional Study) included patients with HR+/HER2- mBC who received treatment with IBRANCE from 110 community and academic centers in the US and Canada (N=1500).¹,²

POLARIS study design1,2

* Case report forms recorded clinical and treatment data from patients’ existing medical charts. 

POLARIS patient characteristics

The interim analysis included the first 522 US patients who completed ≥6 months of IBRANCE treatment as of May 20, 2019.²

75% of enrolled patients received IBRANCE in the first-line setting, and 25% as second or later line.²

Explore More POLARIS PROs Explore more Loading MADELINE overview Explore more LoadingReferencesABC = advanced breast cancer; ANA = anastrozole; EORTC QLQ-C30 = EORTC Core Quality of Life questionnaire;                    
EXE = exemestane; FUL = fulvestrant; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor
2-negative; IBR = IBRANCE; LET = letrozole; mBC = metastatic breast cancer; PFS = progression-free survival;
QoL = quality of life; ORR = objective response rate; OS = overall survival.References:Tripathy D, et al. Future Oncology. 2020;16:2475-2485.Rocque G, et al. SABCS 2019; Poster P19-A-875.POLARIS
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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