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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 overview

MADELINE (Mobile App Diary of Everyday Life and Experiences) was a prospective, non-interventional, multicenter longitudinal study of PROs in women receiving IBRANCE combination therapy for ABC/mBC.¹

MADELINE used a custom-developed, novel mobile application to collect real-time PROs1

MADELINE was one of the first studies to evaluate day-to-day impacts of ABC/mBC and treatment on patients, outside of clinical trials.¹

Site characteristics, treatment patterns, patients characteristics and study endpoints1PRO data were collected at baseline, and then at daily, weekly and cycle-based intervals for 6 months1

Patients received daily reminders to track their pain level, fatigue level and mood.¹

Safety endpoints included the incidence, severity and duration of neutropenia events and other AEs occurring during the study.¹

At each cycle, the relationship between all PROs and neutropenia was explored by comparing patients without neutropenia during the study (for the cycle-based PROs) and patients with neutropenia at the time point.¹

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 patient characteristics Explore more LoadingABC = advanced breast cancer; AE = adverse event; AI = aromatase inhibitor; CES-D-10 = 10-Item Center for Epidemiological Studies Depression Scale; eCRF = electronic case report form; HR+/HER2- = hormone receptor positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; MCS-12 = mental component summary; PCS-12 = physical component summary; QoL = quality of life; PRO = patient-reported outcome; RW = real-world; SF-12 = 12-Item Short Form Health Survey.References:Richardson D, et al. Breast Cancer Res Treat 2021;187:113-124.McRoy LL, et al. SABCS 2016. Poster OT3-03-01.MADELINE
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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