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GeparDouze, the largest neoadjuvant immunotherapy trial in triple-negative breast cancer, found that adding atezolizumab to chemotherapy before and after surgery did not significantly reduce relapses (a 3.3-point gain at four years that missed statistical significance), unlike pembrolizumab in KEYNOTE-522.
NSABP B-59/GeparDouze (NCT03281954) randomised 1,550 patients (773 atezolizumab, 777 placebo) with stage II to III triple-negative breast cancer to sequential taxane, carboplatin and anthracycline neoadjuvant chemotherapy with atezolizumab or placebo, continued after surgery. The primary endpoint, event-free survival, was not significantly improved (hazard ratio 0.80, 95 percent confidence interval 0.62 to 1.03, stratified log-rank p 0.083; four-year rates differed by 3.3 points); the overall survival hazard ratio was 0.86 (0.62 to 1.19) with a 0.7-point four-year difference. A prespecified subgroup analysis suggested benefit in patients with clinical nodal involvement (interaction p 0.039), and an exploratory mRNA analysis pointed to basal-like immune-activated tumours. Grade 3 or worse treatment-emergent adverse events were 75.3 versus 73.4 percent and immune-related adverse events 27.6 versus 11.4 percent; 25.5 percent discontinued atezolizumab in the neoadjuvant phase against 18.8 percent for placebo. Published in Nature Medicine in 2026, the trial leaves pembrolizumab as the only checkpoint inhibitor with an early-stage triple-negative licence.
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.
1,550 enrolled.
Numbers not yet public.
SourceNumbers not yet public.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival (four-year difference 3.3 points)primary | Atezolizumab + chemotherapy | 773 | - | 0.8 (0.62 to 1.03) | 0.083 | link |
| Placebo + chemotherapy | 777 | - | ||||
| Overall survival (four-year difference 0.7 points) | Atezolizumab + chemotherapy | - | - | 0.86 (0.62 to 1.19) | - | link |
| Placebo + chemotherapy | - | - |
Shares Epirubicin, Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer.
Shares Epirubicin, Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer.
Shares NeoTRIP (NeoTRIPaPDL1), Atezolizumab, Roche / Genentech, Cyclophosphamide.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Cyclophosphamide, Doxorubicin.
Shares Epirubicin, Cyclophosphamide, Early triple-negative breast cancer, Platinum agents.
Shares Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer, Platinum agents.
Shares Epirubicin, Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer.
Shares Epirubicin, Cyclophosphamide, Early triple-negative breast cancer, Platinum agents.