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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.

IBRANCE® Real-World Insights (IRIS)

Confidence Through Experience1-9

There is a growing body of RWE for IBRANCE® in the UK and globally to complement PALOMA-2 and PALOMA-3 RCT data and to help support prescribing decisions for appropriate patients with HR+/HER2- ABC.2-12

Learn more about IBRANCE® Real World Evidence.

IRIS is an observational, retrospective chart review of 1723 adult female patients* who have received IBRANCE® (palbociclib) combination treatments in line with locally licensed indications in real-world settings.2,3,10–12 The IRIS UK cohort consisted of 255 patients3

This study aims to evaluate the demographics, clinical characteristics, treatment patterns and outcomes of IBRANCE® combinations in diverse, real-world HR+/HER2- ABC patient populations2,3,10,11,12

Patient baseline characteristics in the IRIS UK cohort were representative of a real-world patient population and similar to patients in the PALOMA clinical trials3,6,8

Ibrance is effective and well tolerated in real world clinical practice in treatment of patients with HR+/HER2- ABC2–5,10–12

In the IRIS UK cohort, 9 out of 10 patients were alive at 2 years (weighted with median patient numbers).3

* Patient number accurate as of May 2020, including patients from Belgium, France, Germany, Italy, the Netherlands, Portugal, Spain, Switzerland and the United Kingdom.11

† Time frame > 24 months where follow-up available. Survival rate defined as the time from the date of initiation of IBRANCE® combination therapy to the date of death due to any cause or end of follow-up (if earlier). Of the 255 patients in the IRIS UK cohort, 221 patients received IBRANCE® + AI (survival rate 92.2%); 34 patients received IBRANCE® + fulvestrant (survival rate 85.2%); the calculated weighted average is 91.3%.

​​​​​​​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.​​​​​

IRIS (UK) Study​​​​​​​

IRIS Study Design3

​​​Study endpoints include :

  • Progression-free rate – proportion of patients with no evidence of progression or death at 6, 12, 18 and 24 months3
  • Survival rate – proportion of patients alive at 6, 12, 18 and 24 months3 
In total, 34 physicians reviewed and extracted data from the medical records of 255 patients treated with IBRANCE® + AI (n=221) or IBRANCE® + fulvestrant (n=34).3

​​​​* EMA approval on 10 November 2016.
​​​​​​​ Index dates vary by physician depending on the date first prescribed.
EMA approval on 10 November 2016, but NICE approval was not received until October 2019; therefore, availability to some physicians may have been limited before this time.

Patient baseline characteristics in the IRIS (UK) cohort were representative of a real-world patient population and similar to patients in the PALOMA clinical trials.3,6,8

Median age was 65 overall; and approximately one quarter of UK patients in the IRIS Study were over 70 years of age and 98% were in menopause.​​​​​​​3

* Additional sites of metastasis included skin/soft tissue, ovary and other (7.9%, 0.4% and 5.0% of the overall population, respectively).

​​​​​​​Metastatic Disease​​​​​​​

​​​​Overall, 50.2% of patients with metastases had visceral disease (n=120), and the most frequent site of metastasis was bone (70.7%)3

Site of Metastases


IBRANCE® in combination with AI/fulvestrant demonstrated favourable efficacy in progression-free rates and survival rates.​​​​​​​3,12​​​​​​​

The 12-month progression-free rates were:3,12 

  • 85.3% in patients receiving IBRANCE® plus AI
  • 74.5% in patients receiving IBRANCE® plus fulvestrant

* Estimated via Kaplan–Meier analysis. Time (days) to progression required to contribute to progression-free rate.​​​​
​​​​​​​† n less than full base where not all patients have known time to progression; status (alive/deceased); or time since death. 

Progression-free rate in patients enrolled in the IRIS (UK) cohort was established by assessing time from initiation until the earliest of:3
- Clinician-documented progression while on treatment with IBRANCE®
- Death
- Start of a new therapy line after final IBRANCE® dose if the reason for discontinuation of IBRANCE® was disease progression
- Last available follow-up

In the IRIS (UK) cohort, 9 out of 10 patients are alive at 2 years (weighted with median patient numbers).3,12

* Survival rates estimated via Kaplan–Meier analysis.

n less than full base where not all patients have known time to progression; status (alive/deceased); or time since death. 
Time from the date of initiation of IBRANCE® combination therapy  to the date of death due to any cause or end of follow-up (if earlier).​​​​​

​​​​​​​Treatment Modification and Dose Adjustment

Consistent with PALOMA clinical trials, IBRANCE® appears to be well tolerated in clinical practice.1,3,6–12

Dose reductions were less common in the IRIS (UK) cohort than in the PALOMA clinical trials.3,6,7,9,10

  • Treatment was discontinued in 21.7% of patients receiving palbociclib + AI and 17.6% of patients treated with palbociclib + fulvestrant3
  • ​​​​​​​The most common reason for discontinuation was disease progression following initial response (82.4%)3

​​​​​​​Permanent discontinuation of palbociclib due to AEs was 2% in the IRIS (UK) cohort3

Reasons for treatment discontinuation

Dose adjustments were infrequent among the total IRIS (UK) cohort, with 19.2% and 1.6% of all patients requiring a dose reduction or interruption, respectively.3 Cycle delays were required by 2% of patients.3 Overall, 80% of the population did not require a dose adjustment.3

Breakdown of Dose Adjustments in the IRIS (UK) Study3

ABC : Advanced Breast Cancer, AI : Aromatase Inhibitor, BE : Belgium, CH : Switzerland, DE : Germany, ECOG PS : Eastern Cooperative Oncology Group performance status, eCRF : electronic Case Report Form, EMA : European Medicines Agency, ET : Endocrine Therapy, HR+/HER2- : Hormone Receptor‑Positive/Human Epidermal Growth Factor Receptor 2-Negative, IRIS : IBRANCE® Real World Insights, IT : Italy, LHRH : Luteinising Hormone‑Releasing Hormone, mBC : metastatic Breast Cancer, NICE : National Institute for Health and Care Excellence, SmPC : Summary of Product Characteristics, UK : United Kingdom

  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Taylor-Stokes G, et al. Breast 2019;43:22–27.
  3. Pfizer Ltd. Data on file. IBRANCE® Real-World Insights (IRIS) – A Global Real-World Study on Palbociclib Outcomes – Results from the UK, 2020.
  4. DeMichele A, et al. Breast Cancer Res 2021;23:37–47
  5. Palmieri C, et al. Poster #1710. Presented at the ESMO Congress 2021
  6. Finn RS, et al. N Engl J Med 2016;375:1925–1936
  7. Rugo HS, et al. Breast Cancer Res Treat 2019;174:719–729
  8. Cristofanilli M, et al. Lancet Oncol 2016;17:425–439
  9. Turner NC, et al. N Engl J Med 2018;379:1926–1936
  10. Waller J, et al. J Glob Oncol 2019;5:JGO1800239.
  11. Mycock K, et al. Poster P510. Presented at the EBCC Virtual Congress, 2–3 October 2020.
  12. Taylor-Stokes G, et al. Poster 269P. Presented at ESMO Virtual Congress, 19–21 September 2020.
PP-IBR-GBR-4083. February 2022

Real-World Evidence

  • Real-world patient data for IBRANCE® in advanced breast cancer

  • IBRANCE® Real World Evidence
  • ROIS

Clinical Trials

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

    ​​​​​​​PALOMA-3 Trial


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  • 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

For UK Healthcare Professionals*

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PP-PFE-GBR-3863. November 2021



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