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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for the UK. IBRANCE® (palbociclib) Prescribing Information for the UK click here. Adverse event reporting information can be found at the bottom of the page.
PALOMA-2 was a randomised, double blind, placebo-controlled Phase III study of IBRANCE (palbociclib) plus letrozole (n=444) versus letrozole alone (n=222) in post-menopausal women with hormone receptor-positive, human epidermal growth factor receptor-negative (HR+/HER2-) locally advanced and metastatic breast cancer who had received no prior systemic therapy for advanced disease.2,3
The study primary endpoint was investigator-assessed progression-free survival (PFS) according to RECIST criteria version 1.1, and a key secondary endpoint was overall survival.3
Adapted From Rugo HS et al. Breast Cancer Res Treat. 2019;174:719-29.2
Data cutoff: May 2017 (median follow-up was 37.6 months in the IBRANCE plus letrozole arm and 37.3 months in the letrozole alone arm).2
*Investigator-assessed PFS was defined as the time from date of randomisation to the date of first documented objective disease progression (per Response Evaluation Criteria in Solid Tumors, v1.1) or death due to any cause, whichever occurred first.2,3
Adapted from Slamon DJ, et al. J Clin Oncol 2024.4
Data cutoff: 15th November 2021 (median follow-up was 90.1 months).4,5
*There was an 80% power to detect an OS difference between treatment arms with a HR of ≤0.74. Given the HR was 0.956 (95% CI: 0.777–1.177), PALOMA-2 did not meet the OS endpoint. OS was defined as time from randomisation to death from any cause.4,5
PALOMA-2 OS subgroup analysis are considered exploratory. The results are descriptive and should be interpreted with caution.
Adapted from Slamon DJ, et al. J Clin Oncol 2024.4
Data cutoff: 15th November 2021 (median follow-up was 90.1 months).4,5
*Figure shows OS from subgroups in the ITT population. Data cut-off: 15th November 2021; median follow-up of 90 months.4,5
Click below to learn more about the PALOMA-2 Trial - including study design, further efficacy outcomes and safety information.
HR+, hormone receptor-positive HER2: human epidermal growth factor 2; PFS: progression-free survival; HR: hazard ratio; CI: confidence interval; RECIST: response evaluation criteria in solid tumours; NE: not estimable; ITT: intention-to-treat. OS, overall survival; ECOG, Eastern Cooperative Oncology Group; ITT, intention-to-treat
References
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