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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
PalomAGE overview

PalomAGE is a French, prospective, non-interventional study which evaluates palbociclib in combination with ET in the clinic in patients aged ≥70 years with HR+/HER2- mBC (N=807).¹

PalomAGE study design1 PalomAGE patient characteristics1

In PalomAGE, cohort A included 400 ET sensitive patients receiving first-line treatment for mBC while cohort B included 407 patients who were ET resistant and/or with prior mBC treatment¹

At baseline in cohort B, almost 36% of patients were in first line and 24% had received more than 2 previous treatment lines.¹

For each variable reported, percentages are calculated on the total of the categories filled for the variable.¹

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.Explore More RWE in older patients Explore more LoadingABC = advanced breast cancer; AE = adverse event; ECOG = Eastern Cooperative Oncology Group; ET = endocrine therapy; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; M = month; mBC = metastatic breast cancer; N/n = number of patients; NCI-CTCAE = National Cancer Institute common terminology criteria for adverse events; PAL = palbociclib; SAE = serious adverse event.References:Caillet P, et al. Oral presentation at ASCO 2021.
PalomAGE
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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