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A-BRAVE tested a year of the immunotherapy avelumab after standard treatment for high-risk triple-negative breast cancer at Italian and eight British hospitals. Relapse-free survival, the main endpoint, was not significantly improved; a later analysis found the benefit concentrated in tumours rich in immune cells.
A-BRAVE (NCT02926196) randomised 466 patients (474 registered) with high-risk early triple-negative breast cancer to one year of adjuvant avelumab or observation after standard therapy, in two strata: stratum A after primary surgery and adjuvant chemotherapy (high risk by pathological stage) and stratum B after neoadjuvant chemotherapy without pathological complete response. The co-primary endpoints were disease-free survival overall and in PD-L1-positive patients; the trial did not reach significance for disease-free survival in its 2024 presentation, with a numerical overall survival advantage. The biomarker analysis (Clinical Cancer Research 2026, 387 patients with baseline TILs and 330 with TILs in residual disease) found that higher baseline and residual-disease TILs were independently prognostic, that residual cancer burden was prognostic but did not predict avelumab benefit, and that avelumab improved outcomes only in tumours with baseline TILs of 30 percent or more: in stratum B three-year distant disease-free survival 92.0 versus 58.7 percent (hazard ratio 0.20) in TIL-high against 70.4 versus 70.1 percent (0.92) in TIL-low tumours (interaction p 0.019). Eight UK hospitals recruited. The primary paper's figures are not indexed on Europe PMC, so the disease-free survival hazard ratio is not quoted here.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
474 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Distant disease-free survival at 3 years, stratum B, baseline TILs 30 percent or more (exploratory) | Avelumab | - | 92% | 0.2 | interaction 0.019 (TIL-low tumours 70.4 versus 70.1 percent, hazard ratio 0.92) | link |
| Observation | - | 58.7% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares ALEXANDRA / IMpassion030, Tumour-infiltrating lymphocytes (TILs), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
Shares Residual cancer burden (RCB), Tumour-infiltrating lymphocytes (TILs), KEYNOTE-522, Early triple-negative breast cancer.
Shares Residual cancer burden (RCB), KEYNOTE-522, Early triple-negative breast cancer, Triple-negative breast cancer trials open today (registry snapshot and UK sites).
Shares Residual cancer burden (RCB), KEYNOTE-522, Early triple-negative breast cancer, Triple-negative breast cancer (TNBC).
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Early triple-negative breast cancer.
Shares Residual cancer burden (RCB), Tumour-infiltrating lymphocytes (TILs), KEYNOTE-522, Early triple-negative breast cancer.
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Early triple-negative breast cancer.
Shares Residual cancer burden (RCB), Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Early triple-negative breast cancer.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/