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Pfizer MedicinesTherapy AreasExplore ContentEventsVideosMaterialsFeatured ArticlesLet’s ConnectSupplyAlliance HealthcareOff-contract claims

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

Ibrance® (palbociclib) Real-World Evidence


RWE and data from RCTs each have their own complementary strengths and weaknesses that, when combined, can help regulators, clinicians and patients to better understand and utilise therapies. 

Please note, observational retrospective analyses are not intended for direct comparison with clinical trials due to differences in study design and settings.

P-VERIFY

The Largest Real-World Comparative Overall Survival Analysis of First-line CDK4/6 Inhibitors + AI in HR+/HER2- mBC to Date

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Duration of Treatment

Treatment duration and subsequent treatments of 1L CDK4/6 Inhibitor + AI for HR+/HER2- mBC
 

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P-REALITY X

Palbociclib Real-World First-Line Comparative Effectiveness Study Extended
 

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Randomised clinical trials (RCTs) and real world evidence (RWE) studies across the world have included patients with mBC treated with IBRANCE

Study numbers represent the number of patients treated with IBRANCE® + AI (n) and the total number of patients in each study (N), as of July 2025.​
* In PARSIFAL-LONG, 209 patients received IBRANCE® + letrozole.2

Strengths and Limitations of RCTs and RWD Studies Perspective on Clinical Trials and Real-World Data   

*Percentage estimated from 67,652 patients with cancer who were recruited into clinical trials in England in the financial year 2018-20194 and 305,683 people diagnosed in with in England in 20175

AI, aromatase inhibitor; mBC, metastatic breast cancer; RCT, randomised controlled trial; RWE, real-world evidence; RWD, real-world data

References

Clinicaltrials.gov NCT01740427. Available at: https://clinicaltrials.gov/study/NCT01740427#contacts-and-locations (accessed April 2026).Llombart-Cussac A, et al. ESMO Open. 2025;10(7):105309.Rugo HS, et al. ESMO Open. 2025;10(1):104103. Rugo HS, et al. NPJ Breast Cancer. 2022;8:114.Brufsky AM, et al. Cancer Med. 2025;14:e70719.Dent S, et al. Cardio-Oncology. 2025;11:7.Dent S, et al. Cardio-Oncology. 2025;11:64.Caillet P, et al. J Clin Oncol. 2021;39:Suppl 15;1012.Kennedy-Martin T, et al. Trials. 2015;16:495.Khozin S, et al. J Natl Cancer Inst. 2017;109; doi: 10.1093/jnci/djx187.Singal AG, et al. Clin Transl Gastroenterol. 2014;5:e45.The Institute of Cancer Research. Clinical trials in cancer. December 2021. Available at: https://www.icr.ac.uk/docs/default-source/migrated-documents/corporate-docs--accounts--and-annual-r… [Accessed April 2026].Office for National Statistics. Cancer registration statistics, England 2017. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsanddiseases/bulletins/cancerregistrationstatisticsengland/2017 [Accessed April 2026].Booth CM, Tannock IF. Br J Cancer. 2014;110:551–555.AkobengAK. Arch Dis Child 2005;90:840–844.Sanson-Fisher RW, et al. Am J Prev Med 2007;33:155–161.SchmidtAF, et al. J Clin Epidemiol 2013;66:599–607.Valentgas P, et al. Making informed decisions:assessing the strengths and weaknesses of study designs and analytic methods for comparative effectiveness research. Available at:  www.npcnow.org/system/files/research/download/experimental_nonexperimental_study_final.pdf [Accessed April 2026].Brufsky A, et al. Presented at ESMO, Berlin, Germany, 17‒21 October 2025. Poster 523P

PP-IBR-GBR-6963. April 2026 

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