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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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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 Study Design and Patient Population

Confidence In A Treatment that’s Setting The Standard1-3

IBRANCE®(palbociclib) + Aromatase Inhibitor

PALOMA-2 was a randomised, double-blind, placebo-controlled, phase III study that assessed the safety and efficacy of IBRANCE® plus letrozole vs placebo plus letrozole as 1st line treatment in a wide range of Aromatase Inhibitor (AI) sensitive post-menopausal patients, including those with bone-only disease (23.2%) and visceral disease (48.2%).

Patients with advanced, symptomatic, visceral spread at the risk of life threatening complications in the short term were excluded from the trial.1,2

* Patients were not eligible if they had relapsed on a non-steroidal AI during or within 12 months of completing adjuvant therapy.2

† According to RECIST criteria, version 1.1.2

Baseline Characteristics​​​​​​​​​​​

Values are n (%) unless otherwise noted.
Adapted from Finn RS, et al. N Engl J Med. 2016;375:1925-1936.2

‡ This is defined as the time from (neo)adjuvant therapy to recurrence – the percentage is based on the number of patients who received (neo)adjuvant therapy.1

§ Patients who progressed while on or within 12 months from completion of prior letrozole or anastrozole were excluded from the study.1


AI : Aromatase Inhibitor, CBR : Clinical Benefit Rate (complete response, partial response or stable disease for >24 weeks), DoR : Duration of Response, ECOG PS : Eastern Cooperative Oncology Group Performance Status, ER : Oestrogen Receptor, HER2- : Human Epidermal growth factor Receptor 2-negative, mBC :  metastatic Breast Cancer, OD : Once Daily, ORR : Objective Response Rate (complete or partial response), OS : Overall Survival, PFS : Progression-Free Survival, PO : by mouth, PROs : Patient-Reported Outcomes, RECIST : Response Evaluation Criteria in Solid Tumours, SD : Standard Deviation

  1. Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.
  2. Finn RS, et al. N Engl J Med. 2016;375:1925-1936.
  3. Cardoso F, et al. Ann Oncol. 2020;31(12):1623-1649.
PP-IBR-GBR-4073. February 2022

PALOMA-2 Trial

IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results

  • Efficacy Outcomes
  • Quality of Life Outcomes
  • Safety Profile
  • IBRANCE® Mode of Action

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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PP-PFE-GBR-3863. November 2021



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