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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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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

Confidence in a Treatment that’s setting the standard1-3

IBRANCE® (palbociclib) + Fulvestrant

Primary results from a Phase III trial of IBRANCE® plus fulvestrant compared with fulvestrant alone in women with HR+/HER2- locally advanced and metastatic breast cancer that progressed on previous endocrine therapy.1-3

Study Design

Study design and patient populations for the Phase III PALOMA-3 Trial

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Efficacy Outcomes

Efficacy outcomes including mPFS, mOS and the impact of prior chemotherapy on IBRANCE® efficacy

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Quality of Life Outcomes

EORTC QLQ-C30 Quality of Life outcomes

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Safety Profile

IBRANCE® Safety Profile and frequently reported adverse events

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Real World Evidence

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

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AI : Aromatase Inhibitor, EORTC QLQ-C30 : European Organisation for Research and Treatment of Cancer Quality Of Life Questionnaire C30,  ET : endocrine therapy, HR+/ HER2- : Hormone Receptor‑Positive/ Human Epidermal Growth Factor Receptor 2-Negative, LHRH : Luteinising Hormone-Releasing Hormone, mOS : Median Overall Survival, mPFS : Median Progression-Free Survival, SmPC : Summary Of Product Characteristics.
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.
PP-IBR-GBR-4308. May 2022

PALOMA-3 Trial

IBRANCE® + Fulvestrant (Ful) Clinical Trial Results

  • ​​​​​​​IBRANCE® PALOMA-3 Trial
  • Study Design
  • Efficacy Outcomes
  • Quality of Life Outcomes
  • Safety Profile

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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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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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PP-PFE-GBR-3863. November 2021

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