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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. IBRANCE® (palbociclib) Prescribing Information for Great Britain click here. IBRANCE® (palbociclib) Prescribing Information for 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 Standard1-2

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 Rugo HS, el al. Breast Cancer Res Treat. 2019;174.719-29
1

‡ 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

 ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

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.
PP-IBR-GBR-3745. July 2021

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

Efficacy

Efficacy results for IBRANCE®

  • IBRANCE® Efficacy

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-2688. December 2020

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