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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 Efficacy Outcomes

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

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;174:719-293.1 
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​​​​​​​

Adapted from Turner NC, et al. 20184
​​​​​​​
c  Data cut-off : Feb 20164
d  Data cut-off : Oct 20154

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

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.
  4. Turner NC, et al. Ann-Oncol. 2018;29:669-80.
PP-IBR-GBR-4074. February 2022

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

    ​​​​​​​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

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PP-PFE-GBR-3863. November 2021

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