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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 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
Effect of IBRANCE on QTc interval

No clinically relevant effects on the QTc interval were reported for IBRANCE at the recommended dose of 125 mg daily1

 PALOMA-2 QTc evaluation

In a PALOMA-2 QTc evaluation sub-study, no clinically relevant effects on the QTc interval were reported for IBRANCE:*2

  • IBRANCE in combination with letrozole at the recommended therapeutic dosing regimen did not prolong the QTc interval to a clinically relevant extent
 ECG not included 

The current SmPC for IBRANCE does not include provisions for ECG monitoring:1

  • Additional monitoring may be necessary based on the individual patient 
  • IBRANCE does not have any special warnings or precautions for use with QTc-prolonging drugs in the current SmPC1
PALOMA-2 (IBRANCE + letrozole vs placebo + letrozole in ET sensitive HR+/HER2- mBC) included a QTc evaluation sub-study as a definitive QT interval prolongation assessment for palbociclib.2 
Time-matched triplicate ECGs were performed at 0, 2, 4, 6, and 8 h at baseline (Day 0) and on Cycle 1 Day 14.² 
Additional ECGs were collected from all patients for safety monitoring.2
The QT interval was corrected for heart rate using Fridericia’s correction (QTcF), Bazett’s correction (QTcB), and a study-specific correction factor (QTcS). No patients in the IBRANCE + letrozole arm of the sub-study had a maximum post-baseline QTcS or QTcF value of ≥480 ms, or a maximum increase from clock time-matched baseline for QTcS or QTcF values of ≥60 ms.2 
The upper bounds of the one-sided 95% confidence interval for the mean change from time-matched baseline for QTcS, QTcF, and QTcB at all time points and at steady-state Cmax following repeated administration of 125 mg IBRANCE were less than 10 ms.2
There was no evidence of clinically significant effects of IBRANCE + letrozole on QTc, the PR interval, or the QRS complex.2
Explore More PALOMA-2 AEs

Well-characterised safety profile

 See AE tables PALOMA-3 AEs

Well-characterised safety profile

 See AE tables
AE = adverse event; ECG = electrocardiogram; ET = endocrine therapy; HR+/ HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; QTc = QT interval corrected for heart rate; QTcB = QT interval Bazett's correction; QTcF = QT interval Fridericia's correction; QTcS = QT interval study-specific correction factor; SmPC = Summary of Product Characteristics.References:IBRANCE Summary of Product Characteristics.Durairaj C, et al. Anticancer Drugs. 2018;29(3):271-280.
Selected safety features
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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