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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
What impact did IBRANCE in combination with fulvestrant have  on patient QoL in PALOMA-3?

Significant delay in time to deterioration in pain symptoms with IBRANCE in combination with fulvestrant in 1st line or later vs placebo + fulvestrant in PALOMA-3 (PROs; secondary endpoint)1

  • Statistically significant difference in global QoL and emotional functioning from baseline vs placebo + fulvestrant*
Median Time to Deterioration (mTTD) in Pain Symptoms*1

Adapted from Harbeck N, et al. 2016.1
Data cut-off date: March 16, 2015.2
*TTD defined as time to ≥10-point increase from baseline. 131 (39.1%) patients in the IBRANCE in combination with fulvestrant group had an event vs 83 (50%) in the placebo +  fulvestrant group.1
Mean overall change from baseline on the EORTC QLQ-C30. Higher scores (range 0–100)  indicated better functioning/QoL or higher symptom severity.1
Visceral metastasis was defined as lung, liver, brain, pleural, or peritoneal  involvement. 59.4% of patients in PALOMA-3 who received IBRANCE + fulvestrant presented  with visceral metastasis (n=206).2 Consistent results shown in a sub-group of 199  patients.2

  • In a post-hoc analysis, IBRANCE in combination with fulvestrant demonstrated a greater decrease in pain symptom scores vs placebo + fulvestrant (-3.3 vs 2.0; p=0.0011)†1
  • In a post-hoc analysis, decreases in pain symptom scores in patients with visceral disease were consistent with those observed in the primary PRO analysis‡1
Explore More PALOMA-3

See triaI design overview

Learn more
CI = confidence interval; EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; FUL = fulvestrant; HR = hazard ratio; n = number of patients; NE = non-estimable; PLA = placebo; PRO = patient-reported outcome; QoL = quality of life; TTD = time to deterioration.References:Harbeck N, et al. Ann Oncol. 2016;27(6):1047-1054.Cristofanilli M, et al. 2016;17(4):425-439.
Patient-reported outcomes PALOMA-3

Progression-free survival 

Review data

Overall survival

Review data

Tumour response

Review data
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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