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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 Quality of Life Outcomes

Confidence without Compromise1-2

The PALOMA-2 study shows that you can offer your patients efficacy without compromising QoL with IBRANCE® in combination with letrozole.1

Patient-reported health-related QOL (HRQOL) outcomes was a secondary objective in the PALOMA-2 trial.

A post-hoc analysis of median TTD in FACT-B scores showed a positive trend favouring IBRANCE® + letrozole vs placebo + letrozole (HR: 0.883; P=0.1900).1*

The difference did not reach statistical significance.1

PALOMA-2: Median TTD in FACT-B scores for the PRO-evaluable population in the ITT population1*†§

​​​​​​​Adapted from Rugo HS, et al. Ann Oncol. 2018;29:888-94.1

* In a population of post-menopausal women with ER+/HER2- locally advanced or metastatic breast cancer who had received no prior systemic treatment for their advanced disease.2

† FACT-B is a 37-item self-reporting instrument containing the 27-question FACT-G survey and a 10-question breast cancer additional concerns scale. A higher score in any FACT-B assessment indicates better QoL. TTD for FACT-B was defined as the duration between baseline and first occurrence of a decrease of ≥7 points in FACT-B score with no subsequent observation of a <7-point decrease1

§ PRO analyses were based on the PRO-evaluable population (i.e., patients in the intent-to-treat [ITT] population with a baseline and >=1 post-baseline assessment before the end of study treatment) 
ER+ : Oestrogen Receptor-positive, FACT-B : Functional Assessment of Cancer Therapy - Breast, HER2- : Human Epidermal growth factor Receptor 2-negative, HR : Hazard Ratio, QoL : Quality of Life, TTD : Time To Deterioration​​​​​​
References
  1. Rugo HS, et al. Ann Oncol. 2018;29:888-94.
  2. Finn RS, et al. N Engl J Med. 2016;375:1925-1936.
PP-IBR-GBR-4075. February 2022

PALOMA-2 Trial

IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results

  • IBRANCE® PALOMA-2 Trial
  • Study Design
  • Efficacy 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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