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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
IRIS PFS and overall survival

IBRANCE in combination with fulvestrant demonstrated effectiveness in patients
with HR+/HER2- ABC/mBC in terms of real-world  progression-free and survival rates*1-4

Progression-free rate defined as proportion of patients with no evidence of progression or death at 6, 12, 18, and 24 months. Survival rate defined as proportion of patients alive at 6, 12, 18, and 24 months.¹-⁴ Censored data.IBRANCE + FUL: Progression-free rates at 12 months not available for Canada and Argentina. Progression-free rates at 24 months not available for US, Canada, Argentina and France. Survival rates at 12 months not available for Argentina. Survival rates at 24 months not available for US, Canada, Argentina and France.¹-⁴ 

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.Explore More POLARIS overview Explore more LoadingP-REALITY survival outcomes Explore more Loading P-REALITY X survival outcomes Explore more LoadingReferencesABC = advanced breast cancer; f/u = follow-up; FUL = fulvestrant; HR+/HER2- = hormone receptor-positive,
human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; PFR = progression-free rate;
PFS = progression-free survival; SR = survival rate.  References:Taylor-Stokes G, et al. Breast. 2019;43:22-27.Mycock K, et al. Curr Oncol. 2021;28:678-688. Waller J, et al. J Glob Oncol. 2019;5:JGO1800239. Mycock K, et al. EBCC 2020; Poster 510. IRIS
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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