Ibrance is indicated for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy.1

Real-world Experience

What is RWD and RWE IBRANCE RWE Initiatives FlatironIRIS
PALOMA was the first clinical trial programme to investigate how a CDK4/6 inhibitor might benefit women with HR+/HER2-ABCand is now also the first to be supported by RWE3
ABC = advanced breast cancer; CDK = cyclin-dependent kinase; EMA = European Medicines Agency; ET = endocrine therapy;
FDA = Food and Drug Administration; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative;
mBC = metastatic breast cancer, RCT = randomised controlled trial; RWE = real-world evidence.

IBRANCE has been evaluated in 3 RCTs in ~1300 women with HR+/HER2- advanced or mBC as part of Pfizer’s robust PALOMA Clinical Trial Programme4-6
ABC = advanced breast cancer; ER+/HER2 - = estrogen receptor-positive, human epidermal growth factor receptor 2-negative; ET = endocrine therapy; HR+/HER2- = hormone receptor positive, human epidermal growth factor receptor 2-negative; mBC = metastatic breast cancer; RCT = randomised controlled trial.

Multiple ongoing real-world studies at varied geographic locations13-20
EHR = electronic health record; PRO = patient-reported outcome; RWE = real-world evidence.



  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 10, 2021.
  2. McCain J. P T. 2015;40(8):511-520.
  3. IBRANCE Data on File.
  4. Finn RS, et al. Lancet Oncol. 2015;16(1):25-35.
  5. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
  6. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
  7. Clinical trials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT00721409. Accessed May 2020.
  8. Clinical trials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT01740427. Accessed May 2020.
  9. Clinical trials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT01942135. Accessed May 2020.
  10. Palbociclib (IBRANCE) US Food and Drug Administation. Resources for Information. Approved drugs. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance. Accessed May 2020.
  11. European Medicines Agency (EMEA). IBRANCE (palbociclib). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/ibrance. Accessed May 2020.
  12. IBRANCE (Palbociclib) Capsules FDA Supplement approval. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019 /207103Orig1s008ltr.pdf. Accessed May 2020.
  13. DeMichele A, et al. SABCS 2019; Poster P1-19-02.
  14. Taylor-Stokes G, et al. Breast. 2019;43:22-27.
  15. Waller J, et al. J Glob Oncol. 2019;5:JGO1800239.
  16. Taylor-Stokes G, et al. ESMO Breast 2020; abstract.
  17. Blum JL, et al. Ann Oncol. 2018;29 (suppl_8):viii90-viii121.
  18. HarbeckN, et al. ESMO Breast 2019; poster 165P.
  19. Kim HS, et al. J Korean Med Sci. 2018;33(34):e213.
  20. Richardson D, et al. ASCO 2020; abstract.

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All rights reserved. Date of preparation: June 2020 PP-IBR-GLB-0254

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