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DosingDosingIBRANCE® Dosing
 
Monitoring Requirements
SafetySafetyIBRANCE® Safety ProfileNeutropeniaAdverse Event ManagementClinical Trials
Clinical TrialsIBRANCE® Clinical TrialsIBRANCE® PALOMA-2 Trial
 
IBRANCE® PALOMA-3 Trial
Real World EvidenceReal World EvidenceIBRANCE® Real World EvidenceIRIS (UK) StudyROIS
 
P-REALITY X
Patient ProfilesThe Ibrance® PatientPatient ProfilesAlison - >65 years with comorbiditiesBecky - Postmenopausal with bone-only diseaseSupport and ResourcesSupport and ResourcesIBRANCE Service SupportMaterials
 
Videos

The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here.  Adverse event reporting information can be found at the bottom of the page.

PALOMA-3 Trial Quality- of-life Outcomes

Confidence in a Treatment that's Setting the Standard1-3

The PALOMA-3 study shows that you can offer patients efficacy without compromising QoL with IBRANCE® in combination with fulvestrant.4

Patient-reported HRQoL was a secondary outcome in the PALOMA-3 study.4

PALOMA-3: Global QoL in the ITT population4

IBRANCE® + fulvestrant generally maintained global QoL (EORTC QLQ-C30); a significant deterioration was observed with fulvestrant alone (p=0.03).4

IBRANCE® + fulvestrant significantly improved emotional functioning compared with fulvestrant alone (p=0.002).4

Adapted from Turner NC, et al. Ann Oncol 2018;29:669–680.5

IBRANCE® plus fulvestrant resulted in more favourable patient QoL scores in all areas whereas patient QoL deteriorated in patients receiving fulvestrant plus placebo.4

PALOMA-3: Deterioration in Global QoL5

A statistically significantly greater delay in time to deterioration in global QoL (EORTC QLQ-C30) was observed with IBRANCE® + fulvestrant compared with fulvestrant alone in patients with visceral metastases (p<0.001).5

A similar trend was observed in patients without visceral metastases, but it was not statistically significant.5

Global QoL in Patients Without Visceral Metastases5

Adapted from Turner NC, et al. 2018. Data cut-off October 2015.5

Global QoL in Patients With Visceral Metastases5

Adapted from Turner NC, et al. 2018. Data cut-off October 2015.5

PALOMA-3: Time to Deterioration in Pain Score4

There was a significant decrease in pain* with IBRANCE® + fulvestrant compared with fulvestrant + placebo (−3.3 vs 2.0, p=0.0011).4

IBRANCE® plus fulvestrant significantly delayed TTD in pain symptoms compared with fulvestrant plus placebo (p<0.001).4

Adapted from Harbeck N, et al. 2016.4
*EORTC QLQ-C30 symptom dimension. In a population of pre-/peri- and postmenopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.4

AI : Aromatase Inhibitor, CI : Confidence Interval, EORCT QLQ-C30 : European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire C30, ET : Endocrine Therapy, HR : Hazard Ratio, HR+/HER2- : Hormone Receptor‑Positive/Human Epidermal Growth Factor Receptor 2-Negative, HRQoL : Health-Related Quality of Life, ITT : Intention-To-Treat, LHRH : Luteinising Hormone-Releasing Hormone, NE : Not Estimable, NR : Not Reached, QoL : Quality of Life, SmPC : Summary of Product Characteristics, TTD : Time to Deterioration.

References

Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.Cristofanilli M, et al. ECJ 2018;104:21-31.Turner NC, et al. N Engl J Med 2018;379:1926–1936 including supplementary appendix.Harbeck N, et al. Ann Oncol 2016;27:1047–1054.Turner NC, et al. Ann Oncol 2018;29:669–680.
PP-IBR-GBR-4358. May 2022
PALOMA-3 TrialClinical TrialsSafety Indication

IBRANCE® is indicated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer:
   - In combination with an aromatase inhibitor; or
  - In combination with fulvestrant in women who have received prior ET

In pre- or perimenopausal women, the ET should be combined with a LHRH agonist

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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