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;174.719-291
‡ 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.
- Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.
- Finn RS, et al. N Engl J Med. 2016;375:1925-1936.
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
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-3863. November 2021
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