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.
Confidence In A Treatment that’s Setting The Standard1-3
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 Finn RS, et al. N Engl J Med. 2016;375:1925-1936.2
‡ 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
IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results
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IBRANCE® safety information and outcomes
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