Alliance A011502
Trial question
What is the role of adjuvant daily aspirin therapy in patients with high-risk non-metastatic breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
99.0% female
1.0% male
N = 3020
3020 patients (3004 female, 16 male)
Inclusion criteria: patients with high-risk non-metastatic breast cancer
Key exclusion criteria: age ≥ 70 years; long-term daily use of oral corticosteroids; use of warfarin, heparin or heparin analogs, clopidogrel, or direct thrombin inhibitors or direct factor Xa inhibitors; history of gastrointestinal bleeding, stroke, AF, myocardial infarction, or grade 4 hypertension
Interventions
N=1510 aspirin (at a daily dose of 300 mg)
N=1510 placebo (matching placebo daily)
Primary outcome
Invasive disease-free survival
9.3
7.4
9.3 %
7.0 %
4.7 %
2.3 %
0.0 %
Aspirin
Placebo
No significant difference ↔
No significant difference in invasive disease-free survival (9.3% vs. 7.4%; HR 1.27, 95% CI 0.99 to 1.63)
Secondary outcomes
No significant difference in overall survival (95.8% vs. 96.6%; HR 0.84, 95% CI 0.58 to 1.22)
Safety outcomes
No significant difference in grade 3 and 4 adverse events.
Conclusion
In patients with high-risk non-metastatic breast cancer, aspirin was not superior to placebo with respect to invasive disease-free survival.
Reference
Wendy Y Chen, Karla V Ballman, Ann H Partridge et al. Aspirin vs Placebo as Adjuvant Therapy for Breast Cancer: The Alliance A011502 Randomized Trial. JAMA. 2024 Apr 29:e244840. Online ahead of print.
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