TROPiCS-02
Trial question
What is the role of sacituzumab govitecan in patients with HR+ and HER2- metastatic breast cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
99.0% female
1.0% male
N = 543
543 patients (538 female, 5 male).
Inclusion criteria: patients with HR+ and HER2- metastatic breast cancer.
Key exclusion criteria: previous treatment with topoisomerase 1 inhibitors; significant CVD or clinically significant ECG abnormality; active serious infection requiring antibiotics; any condition deeming the patient to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
Interventions
N=272 sacituzumab govitecan (intravenous dose of 10 mg/kg once weekly on day 1 and day 8 every 21 days).
N=271 single-agent chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine based on the physician's choice).
Primary outcome
Median progression-free survival
5.5 months
4 months
5.5 months
4.1 months
2.8 months
1.4 months
0.0 months
Sacituzumab
govitecan
Single-agent
chemotherapy
Significant
increase ▲
Significant increase in median progression-free survival (5.5 months vs. 4 months; HR 1.52, 95% CI 1.21 to 1.89).
Secondary outcomes
Significant increase in median overall survival (14.4 months vs. 11.2 months; HR 1.27, 95% CI 1.04 to 1.54).
Significant increase in objective response rate (21% vs. 14%; OR 1.63, 95% CI 1.03 to 2.56).
Significantly longer median time to deterioration of global health status and QoL (4.3 months vs. 3 months; HR 1.33, 95% CI 1.09 to 1.64).
Safety outcomes
No significant differences in adverse events leading to treatment discontinuation, serious treatment-related adverse events.
Conclusion
In patients with HR+ and HER2- metastatic breast cancer, sacituzumab govitecan was superior to single-agent chemotherapy with respect to median progression-free survival.
Reference
Hope S Rugo, Aditya Bardia, Frederik Marmé et al. Sacituzumab Govitecan in Hormone Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol. 2022 Oct 10;40(29):3365-3376.
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