This site is intended only for healthcare professionals resident in the Republic of Ireland




Sign in or RegisterLog out
Our medicinesTherapy areasExplore contentExplore contentMaterialsVideosPodcastsLet’s connectLet's connectContact usSign up



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
MADELINE overview

MADELINE (Mobile App Diary of Everyday Life and Experiences) was a prospective, non-interventional, multicenter longitudinal study of PROs in women receiving IBRANCE combination therapy for ABC/mBC.¹

MADELINE used a custom-developed, novel mobile application to collect real-time PROs1

MADELINE was one of the first studies to evaluate day-to-day impacts of ABC/mBC and treatment on patients, outside of clinical trials.¹

Site characteristics, treatment patterns, patients characteristics and study endpoints1PRO data were collected at baseline, and then at daily, weekly and cycle-based intervals for 6 months1

Patients received daily reminders to track their pain level, fatigue level and mood.¹

Safety endpoints included the incidence, severity and duration of neutropenia events and other AEs occurring during the study.¹

At each cycle, the relationship between all PROs and neutropenia was explored by comparing patients without neutropenia during the study (for the cycle-based PROs) and patients with neutropenia at the time point.¹

Observational retrospective analyses are designed to evaluate associations among variables and cannot establish causality. Observational retrospective analyses are not intended for direct comparison with clinical trials.Explore More MADELINE patient characteristics Explore more LoadingABC = advanced breast cancer; AE = adverse event; AI = aromatase inhibitor; CES-D-10 = 10-Item Center for Epidemiological Studies Depression Scale; eCRF = electronic case report form; HR+/HER2- = hormone receptor positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; MCS-12 = mental component summary; PCS-12 = physical component summary; QoL = quality of life; PRO = patient-reported outcome; RW = real-world; SF-12 = 12-Item Short Form Health Survey.References:Richardson D, et al. Breast Cancer Res Treat 2021;187:113-124.McRoy LL, et al. SABCS 2016. Poster OT3-03-01.
IBRANCE Summary of Product Characteristics Product Characteristics Loading

Legal Category: S1A
Further information is available upon request

PP-IBR-IRL-0649. August 2023

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

PfizerPro AccountPfizerPro Account

Please sign in or register to gain access to information relating to Pfizer medicines and vaccines, medical conditions, patient materials and services.

Sign in or RegisterRegisterAccountLog out

This site is intended only for healthcare professionals resident in the Republic of Ireland. If you are a member of the public wishing to access information on a specific medicine, please visit


This website is brought to you by Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Registered in the Republic of Ireland No. 127002.


Copyright © 2023 Pfizer Limited. All rights reserved.

PP-UNP-IRL-0176. January 2023
For Healthcare Professionals in the Republic of Ireland *

The information contained on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland.

I confirm that I am a healthcare professional resident in the Republic of Ireland.*

I accept and agree to the terms of use.*

If you select 'No', you will be redirected to, where you will be able to access information on Pfizer Healthcare Ireland.

PP-UNP-IRL-0176. January 2023

Yes No
You are now leaving PfizerPro
You are now leaving PfizerPro Ireland. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer. Pfizer accepts no responsibility for the content or services of the linked site.