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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).​​​​​​​

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

PALOMA-3 Trial

Clinical Trials

  • Clinical Trial results for IBRANCE®
  • IBRANCE® Clinical Trials
  • PALOMA-2 Trial

    ​​​​​​​PALOMA-3 Trial

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Safety

IBRANCE® safety information and outcomes

  • IBRANCE® Safety Profile
  • Neutropenia
  • Adverse Event Management

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

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PP-PFE-GBR-3863. November 2021

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