EVER-132-002
Trial question
What is the role of sacituzumab govitecan in patients with HR+ HER2- metastatic breast cancer?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
99.0% female
1.0% male
N = 331
331 patients (329 female, 2 male).
Inclusion criteria: patients with HR+ HER2- metastatic breast cancer.
Key exclusion criteria: previous treatment with topoisomerase 1 inhibitors; known brain metastases; second active malignancy in the past 3 years; HIV infection; active HBV or HCV infection; known history of unstable angina, MI, or congestive heart disease in the past 6 months.
Interventions
N=166 sacituzumab govitecan (at an intravenous dose of 10 mg/kg on days 1 and 8 of every 3-week cycle).
N=165 chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine).
Primary outcome
Median progression-free survival
4.3 months
4.2 months
4.3 months
3.2 months
2.1 months
1.1 months
0.0 months
Sacituzumab
govitecan
Chemotherapy
Significant
increase ▲
Significant increase in median progression-free survival (4.3 months vs. 4.2 months; HR 1.5, 95% CI 1.15 to 1.92).
Secondary outcomes
Significant increase in median overall survival (21 months vs. 15.3 months; HR 1.6, 95% CI 1.14 to 2.13).
No significant difference in objective response rate (20% vs. 15%; OR 1.46, 95% CI 0.82 to 2.61).
Significant increase in clinical benefit rate (38% vs. 22%; OR 2.17, 95% CI 1.33 to 3.55).
Safety outcomes
No significant difference in treatment-emergent adverse events.
Conclusion
In patients with HR+ HER2- metastatic breast cancer, sacituzumab govitecan was superior to chemotherapy with respect to median progression-free survival.
Reference
Binghe Xu, Shusen Wang, Min Yan et al. Sacituzumab govitecan in HR+HER2- metastatic breast cancer: the randomized phase 3 EVER-132-002 trial. Nat Med. 2024 Dec;30(12):3709-3716.
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