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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 were the key features of the PALOMA-3 trial?

PALOMA-3 was a randomised, double-blind, placebo-controlled, Phase III study to assess the efficacy of IBRANCE in combination with fulvestrant in pre-/peri- and post-menopausal women with HR+/HER2- mBC who had progressed on or after prior ET1

PALOMA-3 Trial Design1Adapted from Cristofanilli M, et al. 2016.¹
Defined as progression during or within 1 month after the end of prior ET in the context of metastatic disease or progression during or within 12 months after discontinuation of adjuvant ET. 21% of patients had not received prior treatment for their metastatic disease (1st line). Pre-/peri-menopausal patients received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.¹ Sensitivity to prior hormonal therapy was defined as documented clinical benefit (CR, PR, or SD ≥24 weeks) to ≥1 prior hormonal therapy regimen in the metastatic setting or ≥24 months of adjuvant hormonal therapy before recurrence.¹
Evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.1 ORR was defined as confirmed CR or PR.1CBR was defined as CR or PR or SD for ≥24 weeks.1​​​​​​​ Adapted from Cristofanilli M, et al. 2016.¹Pre-/peri-menopausal patients received goserelin or an alternative LHRH agonist for at least 4 weeks prior to and for the duration of the trial.1,2Explore More PALOMA-2

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AI = aromatase inhibitor; CDK = cyclin-dependent kinase; CNS = central nervous system; CR = complete response; CT = chemotherapy; ECOG = Eastern Cooperative Oncology Group; ET = endocrine therapy; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; IM = intramuscularly; LHRH = luteinising hormone-releasing hormone; mBC = metastatic breast cancer; mTOR = mechanistic target of rapamycin; N/n = number of patients; PI3K = phosphoinositide 3-kinase; PFS= progression-free survival; PR = partial response; RECIST = Response Evaluation Criteria In Solid Tumors; SD = stable disease.References:Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
IBRANCE EPAR Public assessment report. 25 November 2016. Available at:https://www.ema.europa.eu/en/documents/
assessment-report/ibrance-epar-public-assessment-report_en.pdf. Last accessed January 2023.
PALOMA-3
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