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

Search

Menu

Close

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

Menu

Close

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 patient characteristics

MADELINE included a real-world heterogenous population of 139 patients (IBRANCE in combination with AI [n=85] or IBRANCE in combination with fulvestrant [n=54]).¹

Patient demographics*1
Adapted from Richardson D, et al. 2021.1Only patients with at least baseline mobile app data and data in both the screening and enrollment electronic case report forms are included in the full analysis set.

Select baseline characteristics• Median duration between mBC diagnosis and study enrollment was 1 month¹
Adapted from Richardson D, et al. 2021.1No patients with an ECOG performance status of 3 or 4 were reported. Liver, brain, lung/pleura, and ovary metastases were categorized as visceral sites. Bone, lymph node, and skin/soft tissue metastases were categorized as non-visceral sites. Other sites were categorized as visceral or non-visceral by clinical review. Patients who had metastasis at any visceral site were classified as having visceral metastases; those without metastases at any visceral site were classified as having non-visceral metastases.

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 PROs Explore more LoadingAI = aromatase inhibitor; ECOG PS = Eastern Cooperative Oncology Group performance status; mBC = metastatic breast cancer; N/n = number of patients; SD = standard deviation.Reference:Richardson D, et al. Breast Cancer Res Treat. 2021;187:113-124.MADELINE
IBRANCE Summary of Product Characteristics Product Characteristics Loading

Legal Category: S1A
Further information is available upon request

PP-IBR-IRL-0592. January 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 https://www.medicines.ie

 

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 Pfizer.ie, 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.