The Absolute Effect / Evidence / Breast Cancer
A-BRAVE
Clinical question: Does one year of adjuvant avelumab improve DFS after standard curative treatment in high-risk early TNBC?
Registry: NCT02926196 · One underlying study; follow-up publications consolidated.
Phase III · randomized · Evidence cut-off: 8 November 2026
Design, population and eligibility
Investigator-initiated, multicentre randomized phase III study of one year of adjuvant avelumab versus observation in high-risk early TNBC.
466 randomized: 383 in residual-disease post-neoadjuvant stratum B and 83 in high-risk primary-surgery stratum A.
High-risk early TNBC after curative surgery and systemic chemotherapy; either residual invasive disease after neoadjuvant chemotherapy or high pathological nodal/tumour risk after primary surgery and adjuvant chemotherapy.
Median follow-up 52.1 months; primary DFS event target reached in February 2024; published 2025.
Treatment and comparator
Intervention: Avelumab 10 mg/kg IV every 2 weeks for 52 weeks.
Comparator: Observation after completion of standard surgery and (neo)adjuvant chemotherapy.
Primary endpoint: Co-primary DFS in the intention-to-treat population and post-neoadjuvant residual-disease stratum B.
Key efficacy outcomes
3-year DFS, ITT: 68.3% avelumab vs 63.2% control HR 0.81 (95% CI 0.61–1.09); p=0.172.
3-year DFS, stratum B: 66.9% vs 60.7% HR 0.80 (95% CI 0.58–1.10); p=0.170.
3-year OS: 84.8% vs 76.3% HR 0.66 (95% CI 0.45–0.97); descriptive secondary analysis.
Neither co-primary DFS endpoint was met. The OS signal was a descriptive secondary analysis and should not be described as confirmatory superiority. PD-L1 status was prognostic but not predictive for DFS benefit (interaction p=0.155).
Absolute outcome visualization
Three-year DFS and descriptive OS estimates.
Bars display source-reported rates; no rates are inferred from medians. Single-arm outcomes are not comparative effects.
NNT / NNH
No NNT: the co-primary DFS endpoints were negative (p=0.172 ITT; p=0.170 stratum B). The descriptive OS difference is not a confirmatory primary endpoint and should not be used to calculate a definitive NNT.
No NNH is calculated from the available primary abstract. Grade-specific immune-related toxicity and discontinuation rates require full safety-table extraction; they are not inferred.
Toxicity, grade 3–5 harms and treatment burden
Avelumab is associated with immune-mediated adverse events, infusion reactions and potential endocrinopathies. The abstracted primary report does not provide a complete grade 3–5 event table; the page deliberately does not fabricate rates.
Avelumab every two weeks for 52 weeks creates repeated infusion visits and immune-toxicity surveillance after completion of curative treatment.
Quality of life and patient-reported outcomes
No established QoL advantage is demonstrated in the primary DFS report. Treatment burden and immune-related toxicity must be weighed against the absence of proven DFS benefit.
Subgroups and applicability
Stratum B was the larger post-neoadjuvant residual-disease group. PD-L1 was prognostic but not predictive for DFS benefit in the primary report. A 2026 TIL correlative publication is exploratory and does not constitute a new trial or validated selection biomarker.
Critical appraisal and limitations
Negative co-primary DFS endpoints; OS is descriptive; relatively modest sample size; biomarker analyses are exploratory. Avelumab is not interchangeable with perioperative pembrolizumab regimens.
Clinical interpretation
A-BRAVE did not demonstrate a DFS benefit from one year of adjuvant avelumab after curative treatment of high-risk TNBC. The descriptive OS signal merits follow-up but does not override the negative primary endpoints.
Contemporary-practice note (8 November 2026): Historical trial results are separated from current practice. Comprehensive guideline-level freshness review remains pending for this batch; use current disease-specific guidance and multidisciplinary context.