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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 progression-free survival

In PALOMA-3, IBRANCE in combination with fulvestrant in 1st line or later doubled mPFS vs placebo + fulvestrant in patients with progression on/after ET*1,2​​​​​​​

PALOMA-3 PFS* Kaplan-Meier Curve1,2

In a 2:1 randomised, double-blind, Phase III trial of women with HR+/HER2- mBC whose disease progressed following ET (N=521)2

Adapted from Cristofanilli M, et al. 20162 and IBRANCE SmPC.1​​​​​​Evaluated according to RECIST Version1.1.2Data cut-off date: March 16, 2015.
Updated non-prespecified analysis.
Data cut-off date: October 23, 2015.lmprovement in PFS was seen across a broad range of patients

IBRANCE in combination with fulvestrant reduced the risk of disease progression vs placebo+fulvestrant in multiple pre-defined patient subpopulations2,3

Subpopulations included:
  •  
  • Pre-/peri-menopausal women
  • Elderly patients (≥65 years)
  • Patients with visceral metastases
  •  
PALOMA-3 PFS Subgroup Analyses2,3*Adapted from IBRANCE EPAR Public assessment report.3
Data cut-off: 23 October 2015.
*Visceral metastasis was defined as lung, liver, brain, pleural, or peritoneal involvement.2 Sensitivity to prior hormonal therapy is defined as either a) documented clinical benefit (i.e. complete response, partial response or stable disease ≥24 weeks) to at least 1 prior hormonal therapy in the metastatic setting or b) at least 24 months of adjuvant hormonal therapy prior to recurrence.3Disease-free interval is time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy.3 Aromatase inhibitor = anastrazole, letrozole or exemestane. Anti-estrogen = tamoxifen, tamoxifen citrate, toremifene, or toremifene citrate.Other = neither an aromatase inhibitor nor an anti-estrogen.*Evaluated according to RECIST Version 1.1.¹Explore More PALOMA-2

See PALOMA-2 progression-free survival data

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Cl = confidence interval; ECOG = Eastern Oncology Cooperative Group; ET= endocrine therapy; FUL = fulvestrant; HR = hazard ratio; ITT = intention to treat; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; mPFS = median progression-free survival; n = number of patients; PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors; SmPC = Summary of Product Characteristics.References:IBRANCE Summary of Product Characteristics.
Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
IBRANCE EPAR Public assessment report. 25 Nov 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003853/WC500217198.pdf. Accessed January 2023.
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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