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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-2 Trial Safety Profile

Confidence in a Treatment you can Manage1-6

Adapted from Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–292

Treatment-emergent AEs of any cause reported in >10% of patients in either arm (safety population)2

Adapted from Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.2

a All AEs regardless of suspected causal relationship to the study medication; MedDRA (v20.0) coding dictionary applied.2

b Clustered Preferred Terms (PTs) (any event having a PT that is equal to those listed):
anemia includes the PTs anemia, hematocrit decreased, and hemoglobin decreased;
infections includes any PT under the system organ class infections and infestations;
leukopenia includes leukopenia and white blood cell count decreased;
neutropenia includes neutropenia and neutrophil count decreased;
rash includes dermatitis, dermatitis acneiform, rash, rash erythematous, rash maculopapular, rash popular, rash pruritic, and toxic skin eruption;
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.2

c In the palbociclib-letrozole arm, grade 3 and 4 febrile neutropenia were reported in 7 (1.6%) and 1 (0.2%) patients, respectively, at the time of the primary analysis (data cutoff date February 26, 2016) and in 7 (1.6%) and 2 (0.5%) patients after the additional 15 months of follow-up (data cutoff date May 31, 2017). The later data cutoff date included an additional 1 (0.2%) patient who developed grade 4 febrile neutropenia with a very slight fever (38.2 ºC) 1 week after the study drug was permanently discontinued. Because the onset of grade 3 or 4 febrile neutropenia takes a median 28 days to emerge after palbociclib is stopped and residual neutropenia is not uncommon for chemotherapy (nab-paclitaxel was the subsequent line of treatment) 7 days after its discontinuation, the chemotherapy appears to contribute to this SAE.2

d Grade 5 AEs in the palbociclib-letrozole arm were disease progression (n=3), infection (pneumonia) and respiratory failure, pulmonary embolism, acute myocardial infarction, breast cancer, breast cancer metastatic, cardiogenic shock, cardiopulmonary failure, cardiovascular insufficiency and death (all n=1): note, 1 patient had grade 5 pneumonia (infection) and grade 5 respiratory failure; grade 5 AEs in the placebo-letrozole arm were infections (n=3), pulmonary embolism, and cardiac arrest (both n=1); note: grade 5 pulmonary embolism and grade 5 lower respiratory tract infection were reported in 1 patient.2

For full safety information please consult the IBRANCE ® Summary of Product Characteristics


AE : Adverse Event, AI : Aromatase Inhibitor, ALT : Alanine aminotransferase, AST : Aspartate transaminase, ET : Endocrine Therapy, HER2- : Human Epidermal growth factor Receptor 2-negative, HR+ : Hormone Receptor positive, PT : Preferred Term​​​​​​
References
  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29 (supplementary appendix included).
  3. Finn RS, et al. N Engl J Med. 2016;375:1925-1936.
  4. Cristofanilli M, et al. Lancet Oncol. 2016;17:425–39.
  5. Turner NC, et al. Ann-Oncol. 2018;29:669-80.
  6. Verma S, et al. Oncologist. 2016;21:1165-117.
PP-IBR-GBR-4076. April 2022

PALOMA-2 Trial

IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results

  • IBRANCE® PALOMA-2 Trial
  • Study Design
  • Efficacy Outcomes
  • Quality of Life Outcomes
  • IBRANCE® Mode of Action

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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