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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
PALOMA-3 tumour control

In PALOMA-3, IBRANCE in combination with fulvestrant improved tumour response in
pre-/peri-/post-menopausal women

IBRANCE in combination with fulvestrant improved tumour response rates vs placebo + fulvestrant in 1st line and later lines, including patients with visceral metastases1,2

PALOMA-3 Tumour Response1​​​​​​​

In patients with prior resistance to ET and visceral metastases, ORR* was 28% for IBRANCE in combination with fulvestrant (n=200) vs 6.7% with placebo + fulvestrant (n=104)2

Adapted from IBRANCE SmPC.1Data cut-off date: October 23, 2015.Defined as confirmed complete response or partial response.3 Defined as confirmed complete response or partial response or stable disease for ≥24 weeks.3
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PALOMA-2

See PALOMA-2 tumour response data

 Learn more CBR = clinical benefit rate; FUL = fulvestrant; ITT = intention-to-treat; n = number of patients; ORR = objective response rate; PLA = placebo; SmPC = Summary of Product Characteristics.
References:IBRANCE Summary of Product Characteristics.Turner NC, et al. Ann Oncol. 2018;29(3):669-680.Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
PALOMA-3 IBRANCE in the real-world setting

Discover how patients responded to IBRANCE combination therapy in the real-world setting

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IBRANCE Summary of Product Characteristics Product Characteristics Loading

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