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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
Tumour control (secondary endpoint)In PALOMA-2, IBRANCE in combination with letrozole improved tumour response in post-menopausal women​​​​​​​

IBRANCE in combination with letrozole improved tumour response vs placebo + letrozole in 1st line and within visceral subgroups1,2

PALOMA-2 Tumour Response1 Adapted from Finn RS, et al. 2016.1 Data cut-off date: February 26, 2016.1Defined as confirmed complete response or partial response.2 Defined as confirmed complete response, partial response, or stable disease for ≥24 weeks.1 

In patients with visceral metastasis and naïve to ET in the advanced disease setting, ORR was 55.1% for IBRANCE in combination with letrozole (n=214) vs 40% with placebo + letrozole (n=110)2 
 

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CBR = clinical benefit rate; ET = endocrine therapy; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; ITT = intention-to-treat; LET = letrozole; mBC = metastatic breast cancer; n = number of patients; ORR = objective response rate; PLA = placebo.References:Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 
Turner NC, et al. Ann Oncol. 2018;29(3):669-680.
PALOMA-2 P-REALITY real-world study

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IBRANCE Summary of Product Characteristics Product Characteristics Loading

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