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.
Confidence In A Treatment that’s Setting The Standard1-2
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
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.
IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results
Efficacy results for IBRANCE®
IBRANCE® safety information and outcomes
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PP-PFE-GBR-2688. December 2020