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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.
Confidence In Evidence1-4
PALOMA-2 was a phase III trial of IBRANCE® (palbociclib) plus letrozole (n=444) versus placebo plus letrozole (n=222) in post-menopausal women with endocrine receptor-positive, human epidermal growth factor receptor-negative (ER+/HER2-) locally advanced and metastatic breast cancer.1,2
The study primary endpoint was investigator-assessed progression-free survival, and the key secondary endpoint was overall survival.2
Adapted from Rugo HS et al. Breast Cancer Res Treat. 2019;174:719-29.1
Data cutoff: May 2017 (median follow-up was 37.6 months in the IBRANCE plus letrozole arm and 37.3 months in the placebo plus letrozole arm).1
*Investigator-assessed primary endpoint (according to RECIST criteria).1
†In the intention-treat 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.1,2
Adapted from Slamon DJ, et al. J Clin Oncol 2024.3
Data cutoff: November 2021 (median follow-up was 90.1 months).3
*Investigator-assessed secondary endpoint.2
†In the intention-to-treat 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.3
‡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.3
A series of pre-specified exploratory subgroup analyses were performed on the basis of stratification factors and baseline characteristics with no formal statistical testing.3
Adapted from Slamon DJ, et al. J Clin Oncol 2024.3
Data cutoff: November 2021 (median follow-up was 90.1 months).3
*Pre-specified analysis in the intention-to-treat population.3
†Small patient numbers can be a limitation of such analyses. These analyses may not be powered to detect significant differences and were not designed to compare across subgroups. Any comparison between groups should be approached with caution.3
At data cutoff, 45 (10.1%) and five (2.3%) patients were still receiving active treatment in the IBRANCE plus letrozole and placebo plus letrozole arms, respectively. The median duration of treatment was 22.0 and 13.8 months, respectively.3
Click here to learn more about the PALOMA-2 Trial - including study design, further efficacy outcomes and safety information.
ER: endocrine receptor; 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.
References
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