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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 Safety Profile

Confidence In A Treatment That’s Setting The Standard1-3​​​​​​​​​​​​​​

Adapted from Turner NC, et al. 2018​​​​​​​3

Although neutropenia was the most frequently reported AE of any grade, relatively few patients experienced febrile neutropenia (1%) in the PALOMA-3 trial.3

​​​​​​​Neutropenia can be managed with IBRANCE® dose reduction4.

Permanent discontinuation of IBRANCE® due to any adverse event was necessary in 5.2% of patients across the PALOMA trials.4​​​​​​​

Adapted from Turner NC, et al. 2018​​​​​​​3

Treatment-Emergent Adverse Event Reported in ≥10% of patients3​​​​​​​

Adapted from Turner NC, et al. 2018, supplementary appendix.3

In a population of pre-/peri- and post-menopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.3
Grading according to CTCAE 4.0.4
PTs are listed according to MedDRA 17.1:4
*Neutropenia includes neutropenia and neutrophil count decreased; †Leukopenia includes leukopenia and white blood cell count decreased;Infections includes any PT under the system organ class infections and infestations; §Anaemia includes the PTs anaemia, haematocrit decreased, and haemoglobin decreased; Stomatitis includes aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, and stomatitis; **Thrombocytopenia includes platelet count decreased and thrombocytopenia; ††Rash includes dermatitis, dermatitis acneiform, rash, rash erythematous, rash maculopapular, rash popular, rash pruritic, and toxic skin eruption.

AE : Adverse Event, AI: Aromatase Inhibitor, AST ; aspartate aminotransferase, CTCAE : Common Terminology Criteria for Adverse Events, ET : endocrine therapy,  HR+/ HER2- : Hormone Receptor‑Positive/ Human Epidermal Growth Factor Receptor 2-Negative, LHRH : Luteinising Hormone-Releasing Hormone, MedDRA : Medical Disctionary for Regulatory Activities,  PT : Preferred Term,  SmPC : Summary Of Product Characteristics.​​​​​​​
  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. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
PP-IBR-GBR-3576. 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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IBRANCE® safety information and outcomes

  • IBRANCE® Safety Profile
  • Neutropenia
  • Adverse Event Management


  • 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*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

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*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021



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