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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
Study Design and Patient Population​​​​​​​​​​​​​

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

​​​​​​

PALOMA-3 was a double-blind, randomised phase III study that assessed the efficacy and safety  of IBRANCE® plus fulvestrant versus fulvestrant plus placebo as second-line therapy in women with HR+/HER2- locally advanced and metastatic breast cancer that had progressed on previous ET.1-3

Patients with uncontrolled brain metastases or extensive, symptomatic visceral spread who were at risk of life-threatening complications in the short term were excluded from the study.1-3

* Disease relapse or progression had to occur after previous ET (with an aromatase inhibitor if the patient was postmenopausal or with tamoxifen if premenopausal or perimenopausal) while on or within 1 month after treatment in the advanced setting, or while on or within 12 months of completion of adjuvant therapy irrespective of menopausal status.1
† All pre- or perimenopausal women received an LHRH agonist for at least 4 weeks prior to, and for the duration of, the trial.1,2
‡ Investigator-assessed PFS according to RECIST (version 1.1).1,2

Baseline Characteristics1

Adapted from Cristofanilli M, et al. 2016.1

§ As per protocol, visceral refers to lung, liver, brain, pleural and peritoneal involvement and was a study stratification factor.1
¶ Data were unavailable for one patient in the intent-to-treat fulvestrant plus placebo group.1
** Disease-free interval was defined as time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy. Data for disease-free interval were available only for patients who were initially diagnosed with early breast cancer and then experienced disease relapse; percentages are calculated on the basis of available data.1
†† Previous sensitivity to ET was based on randomisation.1


AI : Aromatase Inhibitor, CBR : Clinical Benefit Rate (complete response, partial response or stable disease for 24 weeks duration or longer), DoR : Duration of Response, ECOG : Eastern Cooperative Oncology Group, ECOG PS : Eastern Cooperative Oncology Group Performance Status, ET : Endocrine Therapy, HR+/HER2- : Hormone Receptor Positive / Human Epidermal growth factor Receptor 2-negative, IM : Intramuscular, ITT : Intention-To-Treat, LHRH : Luteinising Hormone-Releasing Hormone, mBC : metastatic Breast Cancer, OD : Once Daily, ORR : Objective Response Rate (complete or partial response), OS : Overall Survival, PFS : Progression-Free Survival, PO : Oral, PRO : Patient-Reported Outcome, RECIST : Response Evaluation Criteria In Solid Tumours, 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.
PP-IBR-GBR-3573. May 2022

PALOMA-3 Trial

IBRANCE® + Fulvestrant (Ful) Clinical Trial Results

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

Clinical Trials

  • Clinical Trial results for IBRANCE®
  • IBRANCE® Clinical Trials
  • PALOMA-2 Trial

    ​​​​​​​PALOMA-3 Trial

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Real World Evidence

Real-world patient data for IBRANCE® in advanced breast cancer
  • IBRANCE® Real World Evidence
  • ROIS
  • IRIS (UK) Study
  • P-REALITY

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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