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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
IBRANCE-associated AEs may be effectively managed using a clear dose-modification schedule1

Adapted from IBRANCE Summary of Product Characteristics.1

Dose reductions or dose modifications due to any AE occurred in 38.4% of patients receiving IBRANCE in randomised clinical studies regardless of the combination1

*If further dose reduction below 75 mg/day is required, discontinue the treatment1
Dose Modification and Management of Haematological Toxicities1Cycle 1 Cycle 2Cycle 3
  • CBC to be repeated on Day 1 of each following cycle
  • For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, CBCs for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated
  • Dose reductions for uncomplicated Grade 3 neutropenia should only be performed at the initiation of a cycle and not during a cycle
Dose Modification and Management of Non-haematological Toxicities1All cyclesDose modification includes temporary dose interruptions, cycle delays, and/or reductions.
Grading according to CTCAE 4.0.2
Applies to all haematological adverse events except lymphopenia (unless associated with clinical events, e.g. opportunistic infections). ANC: Grade 1: ANC <LLN – 1500/mm3; Grade 2: ANC 1000 – <1500/mm3; Grade 3: ANC 500 – <1000/mm3; ​​​​​​​Grade 4: ANC <500/mm3Proactively monitor CBC.AE = adverse event; ANC = absolute neutrophil count; CBC = complete blood count; CTCAE = Common Terminology Criteria for Adverse Events; HR+/HER2 - = hormone receptor-positive, human epidermal growth factor receptor 2-negative; LLN = lower limit of normal.
References:IBRANCE Summary of Product Characteristics.National Cancer lnstitute. CTCAE v.4.0. Available at: CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed January 2023.
Recommended dosing
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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