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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
MADELINE patient characteristics

MADELINE included a real-world heterogenous population of 139 patients (IBRANCE in combination with AI [n=85] or IBRANCE in combination with fulvestrant [n=54]).¹

Patient demographics*1
Adapted from Richardson D, et al. 2021.1Only patients with at least baseline mobile app data and data in both the screening and enrollment electronic case report forms are included in the full analysis set.

Select baseline characteristics• Median duration between mBC diagnosis and study enrollment was 1 month¹
Adapted from Richardson D, et al. 2021.1No patients with an ECOG performance status of 3 or 4 were reported. Liver, brain, lung/pleura, and ovary metastases were categorized as visceral sites. Bone, lymph node, and skin/soft tissue metastases were categorized as non-visceral sites. Other sites were categorized as visceral or non-visceral by clinical review. Patients who had metastasis at any visceral site were classified as having visceral metastases; those without metastases at any visceral site were classified as having non-visceral metastases.

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 MADELINE PROs Explore more LoadingAI = aromatase inhibitor; ECOG PS = Eastern Cooperative Oncology Group performance status; mBC = metastatic breast cancer; N/n = number of patients; SD = standard deviation.Reference:Richardson D, et al. Breast Cancer Res Treat. 2021;187:113-124.
MADELINE
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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