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ALEXANDRA asked whether a year of the immunotherapy atezolizumab added to chemotherapy after surgery stops triple-negative breast cancer coming back. It did not: relapses were no fewer, side effects were more, and the trial was stopped early for futility.
ALEXANDRA/IMpassion030 (NCT03498716) randomised 2,199 patients undergoing surgery as initial treatment for stage II or III triple-negative breast cancer between August 2018 and November 2022 to 20 weeks of standard adjuvant chemotherapy with (1,101) or without (1,098) atezolizumab for up to one year. The independent data monitoring committee halted enrolment at 2,199 of 2,300 planned patients and all atezolizumab was stopped after a planned interim and futility analysis. At a median follow-up of 32 months invasive disease-free survival events had occurred in 141 patients (12.8 percent) on atezolizumab and 125 (11.4 percent) on chemotherapy alone (stratified hazard ratio 1.11, 95 percent confidence interval 0.87 to 1.42, p 0.38). Grade 3 or 4 treatment-related adverse events were 54 versus 44 percent with similar fatal events (0.8 versus 0.6 percent) and chemotherapy exposure. Published in JAMA in January 2025, it is the clearest negative result for adjuvant-only checkpoint inhibition in this disease, and with GeparDouze and NeoTRIP it ended atezolizumab's early-stage programme.
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.
2,199 enrolled.
141 events (12.8 percent) · 125 events (11.4 percent)
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive disease-free survivalprimary | Atezolizumab + chemotherapy | 1,101 | 141 events (12.8 percent) | 1.11 (0.87 to 1.42) | 0.38 | link |
| Chemotherapy alone | 1,098 | 125 events (11.4 percent) |
Shares IMpassion031, GeparDouze / NSABP B-59, Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522.
Shares Epirubicin, Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer.
Shares Epirubicin, Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer.
Shares Epirubicin, Cyclophosphamide, Early triple-negative breast cancer, Paclitaxel / nab-paclitaxel.
Shares Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer, Paclitaxel / nab-paclitaxel.
Shares Atezolizumab, Roche / Genentech, Cyclophosphamide, Doxorubicin.
Shares Event-free / disease-free survival (EFS, DFS, iDFS, RFS), KEYNOTE-522, Cyclophosphamide, Doxorubicin.
Shares Epirubicin, Cyclophosphamide, Doxorubicin, Early triple-negative breast cancer.