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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 mBCP-VERIFYP-VERIFY StudyPatient-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 provisionPrescribing Information ResourcesMaterials
What types of patients were enrolled in the PALOMA-2 clinical trial? 

PALOMA-2 included a broad patient population, including 22.3% of patients who had a disease-free interval (DFI) ≤12 months (40.1% DFI >12 months)1

PALOMA-2 Patient Baseline Characteristics1
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Adapted from Finn RS, et al. 2016.1
Data cut-off date: February 26, 2016. Some percentages do not sum to 100 because of rounding.There were no significant differences in baseline characteristics between the two treatment groups except for ECOG performance status (p=0.004). Some percentages do not sum to 100 because of rounding.
DFI was defined as the time from completion of adjuvant or neoadjuvant therapy to recurrence. Newly metastatic disease applies to patients who had not received any prior systemic therapy, for whom a determination of DFI was not possible.1Patients who received anastrozole or letrozole as a component of their adjuvant or neoadjuvant therapy were excluded from the study if they had disease progression while receiving the therapy or within 12 months after completing the therapy.1Explore More PALOMA-3

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ECOG = Eastern Cooperative Oncology Group; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; LET = letrozole; mBC = metastatic breast cancer; n = number of patients; PLA = placebo.References:Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
PALOMA-2
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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