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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

References
  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

  • IBRANCE® PALOMA-2 Trial
  • 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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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

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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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*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021

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