DESTINY-Breast04 Subgroup Analyses: Safety Results (January 11, 2022 DCO Date)1
Safety Results1
- The overall safety profile was generally consistent between patients who received CDK4/6i and those who did not, as well as in patients with low and high disease burden.1
- Rates of study drug discontinuation were similar across subgroups and no differences in the ILD rates were observed across these subgroups.1
- A safety analysis for rapid progressors was not conducted due to small sample size.1
Safety by Prior CDK4/6i Use1
Safety by Prior CDK4/6i Use1
aAdjudicated ILD events per the ILD Adjudication Committee.
Safety by Disease Burden1,a
Safety by Disease Burden1,a
aDisease burden was defined by the number of metastatic disease sites at baseline (low = 0-2; high = 3+). At baseline, 69.8% of patients had liver metastases; bAdjudicated ILD events per the ILD Adjudication Committee.
Abbreviations
CDK4/6i = cyclin-dependent kinase 4/6 inhibitor
;DCO = data cut-off
;ILD = interstitial lung disease
;T-DXd = trastuzumab deruxtecan
;TEAEs = treatment emergent adverse events
;TPC = treatment of physician's choice
References
Document ID: 0ecc6373-81f6-4b23-8e10-3edcd30e370b
Last updated: 06-March-2023
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