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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 ARsPooled 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 were the key features of the PALOMA-2 trial?

PALOMA-2 was a randomised, double-blind, placebo-controlled, Phase III study to assess the safety and efficacy of IBRANCE in combination with letrozole as 1st-line treatment in a wide range of post-menopausal women with ER+/HER2- mBC1

PALOMA-2 Trial Design1​​​​​​​Adapted from Finn RS, et al. 2016.1Evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.1 ORR was defined as confirmed complete response (CR) or partial response (PR).1 CBR was defined as confirmed CR, PR, or stable disease (SD) for ≥24 weeks.1PALOMA-2 lnclusion and Exclusion Criteria1​​​​​​​ Adapted from Finn RS, et al. 2016.1Explore More PALOMA-3

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CNS: central nervous system; DFI = disease-free interval; ECOG = Eastern Cooperative Oncology Group; ER+/HER2– = estrogen receptor-positive, human epidermal growth factor receptor 2-negative; N/n = number of patients; mBC = metastatic breast cancer; PFS = progression-free survival; QTc = QT interval corrected for heart rate; RECIST = Response Evaluation Criteria In Solid Tumors.References:Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
IBRANCE EPAR Public assessment report. 25 November 2016. Available at: http://www.ema.europa.eu/ema/index.
jsp?curl=pages/medicines/human/medicines/003853/human_med_002034.jsp&mid=WC0b01ac058001d124.
Accessed January 2023.
PALOMA-2
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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