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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.​​​​​​​
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.
  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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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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PP-PFE-GBR-3863. November 2021

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