# ALEXANDRA / IMpassion030

Source: https://onco.cc/trials/impassion030/  
OnCo record `impassion030` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-24
- Also known as: ALEXANDRA; IMpassion030; BIG 16-05; AFT-27
- Registry id: NCT03498716
- Phase: 3
- Setting: Stage II to III triple-negative breast cancer treated with surgery first: adjuvant paclitaxel then dose-dense anthracycline and cyclophosphamide with or without atezolizumab for up to one year, 330 centres in 31 countries
- Sponsor: Hoffmann-La Roche, with the Breast International Group and Alliance Foundation Trials
- Enrolled: 2199
- Result: iDFS HR 1.11 (0.87 to 1.42), p 0.38; stopped for futility at 2,199 of 2,300 patients.
- Outcomes: Invasive disease-free survival: Atezolizumab + chemotherapy vs Chemotherapy alone, HR 1.11
- Replication: Consistent with GeparDouze (neoadjuvant and adjuvant atezolizumab, not significant); A-BRAVE (adjuvant avelumab) showed benefit only in TIL-high tumours in exploratory analysis.

## Notes

- UK sites (registry, 6): NHS Lothian Western General Hospital Edinburgh, Calderdale and Huddersfield NHS Foundation Trust, Leeds Teaching Hospitals (St James's), the Christie Manchester, Nottingham University Hospitals City Hospital, Royal Stoke University Hospital.

## Sources

- ClinicalTrials.gov NCT03498716: https://clinicaltrials.gov/study/NCT03498716
- Ignatiadis et al., JAMA 2025: adjuvant atezolizumab for early triple-negative breast cancer, ALEXANDRA/IMpassion030: https://doi.org/10.1001/jama.2024.26886

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Atezolizumab](https://onco.cc/drugs/atezolizumab/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Epirubicin](https://onco.cc/drugs/epirubicin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/)
- trials: [A-BRAVE](https://onco.cc/trials/a-brave/), [GeparDouze / NSABP B-59](https://onco.cc/trials/gepardouze/), [IMpassion031](https://onco.cc/trials/impassion031/), [KEYNOTE-522](https://onco.cc/trials/keynote-522/), [SWOG S1418 / NRG BR006](https://onco.cc/trials/swog-s1418/)

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