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

Established safety profile

Overview Adverse events in PALOMA-3 Adverse events in PALOMA-3
AEs (≥10%) reported in PALOMA-3 (safety population)2

​​​​​​​Adapted from Cristofanilli M, et al. 2016.2

Grading according to CTCAE 4.0 and MedDRA 18.0. Data cut-off date: March 16, 2015. Data are n (%) unless otherwise specified.2
*One other case of pleural effusion that was not graded also occurred in the IBRANCE + FUL group. Reported causes of death were neutropenic sepsis, multiple organ failure, and disease progression based on latest site follow-up information.

AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; FUL = fulvestrant;
MedDRA = Medical Dictionary for Regulatory Activity; n = number of patients;  PLA = placebo.​​​​​​​


  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.

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

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