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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 letrozole have on patient QoL in PALOMA-2?

No differences were observed in overall mean change from baseline with 1st line IBRANCE in combination with letrozole vs placebo + letrozole in FACT-B total and FACT-G total scores in PALOMA-2 (PROs; secondary endpoint)*1

Between-treatment Comparison of Overall Change from Baseline in FACT-B Scores (FACT-B, FACT-G, and TOI)*1 Download chart Adapted from Rugo HS, et al. 2018.1FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. A higher raw score on the pain item indicates higher pain severity. Between-treatment comparisons were non-statistically significantly different for all scales and domains.

In a post-hoc analysis, there was a greater improvement in pain scores observed with IBRANCE in combination with letrozole vs placebo + letrozole:1

  • -0.256 vs -0.098
Between-treatment Comparison of Overall Change from Baseline in FACT-B Total Score by Subgroups*2

In a non-prespecified subgroup analysis, no differences were observed in overall mean change from baseline with 1st line IBRANCE in combination with letrozole vs placebo + letrozole in FACT-B total score across all subgroups studied in PALOMA-2 (PROs; secondary endpoint)*2

Download chart Adapted from Rugo HS, et al. 2019.2FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. A higher raw score on the pain item indicates higher pain severity. Between treatment comparisons were non-statistically significantly different for all scales and domains.1Explore More PALOMA-2

See triaI design overview

Learn more
Cl = confidence interval; ECOG PS = Eastern Cooperative Oncology Group performance status; FACT-B = Functional Assessment of Cancer Therapy - Breast; FACT-G = Functional Assessment of Cancer Therapy - General; IBR = IBRANCE; LET = letrozole; NS = not significant; PLA = placebo; PRO = patient-reported outcome; QoL = quality of life; TFI = treatment-free interval; TOI = Trial Outcome lndex.References:Rugo HS, et al. Ann Oncol. 2018;29(4):888-894.Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729.
Patient-reported outcomes PALOMA-2

Progression-free survival 

Review data
PALOMA-2

Tumour response

Review data
IBRANCE Summary of Product Characteristics Product Characteristics Loading

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