This site contains promotional information intended only for healthcare professionals resident in the United Kingdom

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

See all Therapy areas

Explore Content

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 Efficacy Outcomes

Confidence In A Treatment that’s Setting The Standard1-2

Median Progression Free Survival1ab 

1st line IBRANCE® + letrozole achieved 27.6 months median progression free survival (mPFS) vs. 14.5 months with letrozole + placebo (HR: 0.56 (95% Cl: 0.46-0.69).1a*

Median follow-up was 37.6 months in the IBRANCE® + letrozole arm and 37.3 months in the placebo + letrozole arm.1

PALOMA-2 : Investigator-assessed mPFS (ITT population)1*

Adapted from Rugo HS et al. Breast Cancer Res Treat. 2019;174:719-291

The primary endpoint was investigated assessed PFS, according to RECIST criteria1

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

Patient Subgroups

IBRANCE® + letrozole resulted in a PFS benefit across all patient subgroups in the PALOMA-2 trial, including those with visceral disease.1a*

PALOMA-2 : Investigator-assessed PFS overall and across the subgroups (ITT population)1*

Adapted from Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719-293.
Data cut-off: May 2017

Subgroup analyses by baseline characteristics were pre-specified.

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

1-sided P-value from the log rank test.1

Per tumour site.1

§ In this analysis, the protocol-defined disease-free interval is equivalent to TFI and refers to TFI since completion of prior (neo)adjuvant therapy and onset of metastatic disease or disease recurrence.1

​​​​​​​II A few patients initially enrolled into the trial as having measurable disease were later found to have non measurable disease beyond bone-only disease.1

​​​​​

Patients with Visceral Diease

The PALOMA-2 and PALOMA-3 Clinical Trials involved women with HR+/HER2-locally advanced or metastatic breast cancer.1,2,4 Both trials included patients with and without visceral metastases.1,2,4

Women in PALOMA-2 had not yet received ET for advanced disease, whereas women in PALOMA-3 had received ET for advanced disease and progressed.1,2,4​​​​​​​

i  Data cut-off : May 20171
j  
Data cut-off : February 20164
Data cut-off : May 20171

Delay to Chemotherapy

In PALOMA-2, the median time to first-line subsequent chemotherapy was 40.4 months for the IBRANCE® + letrozole arm vs 29.9 months for the placebo + letrozole arm.1*

PALOMA-2 : Median time from randomisation to first subsequent chemotherapy (ITT population)1*

Adapted from Rugo HS et al. Breast Cancer Res Treat. 2019;174:719-291

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

Tumour Response Rate

IBRANCE® + letrozole resulted in a significant improvement in CBR and a trend towards improved ORR vs letrozole + placebo.2*

Adapted from Finn RS, et al. N Engl J Med. 2016;375:1925–36.2

​​​​​​​* 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

Clinical benefit response comprises of complete response, partial response or stable disease for ≥24 weeks.2

​​​​​​a Phase lll, double-blind, placebo-controlled, randomised study of a population composed of 666 post-menopausal women with ER+/HER2- advanced breast cancer who had received no prior systemic therapy for advanced disease; patients were randomised 2:1 to receive IBRANCE plus letrozole or placebo plus letrozole2

b According to investigator assessment (ITT population); primary endpoint of the PALOMA-2 trial2​​​​​​​


AI : Aromatase Inhibitor, CBR : Clinical Benefit Response, CI : Confidence Interval, ECOG : Eastern Cooperative Oncology Group, EORTC OLO-C30 : European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, ER+ : Oestrogen Receptor-positive, ET : Endocrine Therapy, FACT-B : Functional Assessment of Cancer Therapy-Breast, HER2- : Human Epidermal growth factor Receptor 2-negative, HR : Hazard Ratio, HR+ : Hormone Receptor-positive, IA : Investigator Assessed, ITT : Intention-To-Treat, LET : Letrozole, mBC : metastatic Breast Cancer, mPFS : median Progression Free Survival, mTTR : median Time To Response, NE : Not Estimable, OR : Odds Ratio, ORR : Objective Response Rate, QoL : Quality of Life, PFS : Progression-Free Survival, TFI : Treatment-Free Interval, TTD : Time To Deterioration

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.
  3. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  4. Turner NC, et al. Ann-Oncol. 2018;29:669-80.
PP-IBR-GBR-3746. July 2021

Paloma-2 Trial

IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results

  • IBRANCE® PALOMA-2 Trial
  • Study Design
  • Quality of Life Outcomes
  • Safety Profile
  • IBRANCE® Mode of Action

Clinical Trials

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

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

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.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*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

Yes

No