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 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 mBCP-VERIFYP-VERIFY StudyPatient-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 provisionPrescribing Information 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 PALOMA-3

Overall survival

 Review data PALOMA-3

Tumour response

 Review data
IBRANCE Summary of Product Characteristics Product Characteristics Loading

Legal Category: S1A
Further information is available upon request

PP-IBR-IRL-0734 January 2025

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 Unlimited Company, The Watermarque Building, Ringsend Road, Dublin 4, Dublin, Ireland, D04 K7N3.  Registered in the Republic of Ireland No. 127002. Directors: D. Mangone (Managing), O. Gavan, D. Kennedy. Company Secretary: M.Byrne.  

 

Copyright © 2024 Pfizer Limited. All rights reserved.
 

PP-UNP-IRL-0832. October 2024
For Healthcare Professionals in the Republic of Ireland *

The information on this site is reserved exclusively for healthcare professionals resident in the Republic of Ireland and contains promotional content.

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

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

*The IPHA Code definition of a healthcare professional is a person of any of the following classes: (i) Registered medical practitioners (ii) Registered dentists (iii) Registered pharmacists (iv) Registered nurses

Terms of use

PP-UNP-IRL-0832. October 2024

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.


PP-UNP-IRL-0832. October 2024