ALEXANDRA/IMpassion030
Trial question
What is the role of adjuvant atezolizumab in patients with early triple-negative breast cancer at high risk for recurrence?
Study design
Multi-center
Open label
RCT
Population
2199 patients (2195 female, 4 male).
Inclusion criteria: adult patients undergoing surgery for stage II or III nonmetastatic triple-negative breast cancer.
Key exclusion criteria: history of invasive breast cancer; any T4 tumor; prior systemic anticancer treatment for current breast cancer; prior anthracycline, taxane, or immune checkpoint inhibitor therapy.
Interventions
N=1101 adjuvant atezolizumab (adjuvant atezolizumab immunotherapy for 1 year with standard combination chemotherapy for 20 weeks).
N=1098 chemotherapy alone (standard combination chemotherapy alone for 20 weeks).
Primary outcome
Invasive disease-free survival at 3 years
84.6%
86.4%
86.4 %
64.8 %
43.2 %
21.6 %
0.0 %
Adjuvant
atezolizumab
Chemotherapy
alone
No significant
difference ↔
No significant difference in invasive disease-free survival at 3 years (84.6% vs. 86.4%; HR 0.9, 95% CI 0.7 to 1.15).
Secondary outcomes
No significant difference in overall survival at 3 years (92.3% vs. 93.7%; ARD -1.3, 95% CI -3.8 to 1.2).
No significant difference in recurrence-free survival at 3 years (86.7% vs. 87.7%; ARD -1, 95% CI -4.2 to 2.2).
No significant difference in disease-free survival at 3 years (84.3% vs. 85.3%; ARD -1.1, 95% CI -4.5 to 2.4).
Safety outcomes
No significant difference in adverse events and treatment-related adverse events.
Conclusion
In adult patients undergoing surgery for stage II or III nonmetastatic triple-negative breast cancer, adjuvant atezolizumab was not superior to chemotherapy alone with respect to invasive disease-free survival at 3 years.
Reference
Michail Ignatiadis, Andrew Bailey, Heather McArthur et al. Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA / IMpassion030 Randomized Clinical Trial. JAMA. 2025 Jan 30:e2426886. Online ahead of print.
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