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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
What impact did IBRANCE in combination with fulvestrant have  on patient QoL in PALOMA-3?

QoL scores, including physical, social and emotional functioning, were maintained from baseline with IBRANCE in combination with fulvestrant and placebo + fulvestrant in 1st line or later in PALOMA-3 (PROs; secondary endpoint):1

  • Statistically significant difference in global QoL and emotional functioning from baseline vs placebo + fulvestrant*
Mean Overall Change from Baseline on EORTC QLQ-C30*1Adapted from Harbeck N, et al. 2016.1
Data cut-off December 5, 2014 used for interim analysis; median follow-up 5.6 months
Mean overall change from baseline on the EORTC QLQ-C30. Higher scores (range 0–100) indicated better functioning/QoL or higher symptom severity. The changes from baseline that were statistically significantly different between treatment groups were for Global QoL and emotional functioning.1Time to deterioration was defined as a decrease of ≥10 points from baseline, with no subsequent increase above this threshold.1.

In a post-hoc analysis, there was a greater delay in QoL deterioration observed with IBRANCE in combination with fulvestrant vs placebo + fulvestrant (HR=0.641; p=0.0065)†1

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EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; FUL = fulvestrant; HR = hazard ratio; n = number of patients; NS = not significant; PLA = placebo; QoL = quality of life.References:Harbeck N, et al. Ann Oncol. 2016;27(6):1047-1054.  
Patient-reported outcomes PALOMA-3

Progression-free survival 

Review data
PALOMA-3

Overall survival

Review data
PALOMA-3

Tumour response

Review data
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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