# A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Source: https://onco.cc/trials/nct06112379/  
OnCo record `nct06112379` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide and Carboplatin in HR-positive / HER2-negative breast cancer, run by AstraZeneca, active and no longer recruiting.

## Summary

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer. ClinicalTrials.gov record last updated 2026-07-13: active not recruiting. Enrollment is actual at 1902 participants. Primary completion is estimated at 2028-11-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide, Paclitaxel, Carboplatin, Capecitabine, Olaparib. Registered primary measures: Event-free survival (EFS) in the experimental vs control arms.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-10-06
- Also known as: TROPION-Breast04
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06112379
- Phase: 3
- Setting: A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
- Sponsor: AstraZeneca
- Enrolled: 1902

## Notes

- ClinicalTrials.gov record last updated 2026-07-13: active not recruiting. Enrollment is actual at 1902 participants. Primary completion is estimated at 2028-11-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.
- TROPION-Breast04 (design, Therapeutic Advances in Medical Oncology 2025): neoadjuvant datopotamab deruxtecan with durvalumab then adjuvant durvalumab with or without chemotherapy, against the KEYNOTE-522 regimen, in untreated triple-negative or hormone-receptor-low HER2-negative breast cancer; 1,902 patients randomised (registry actual), primary endpoint event-free survival, primary completion November 2028. UK sites (registry, 7): Birmingham, Cardiff, Lancaster, London, Northampton, Oxford, Taunton.

## Sources

- ClinicalTrials.gov NCT06112379: https://clinicaltrials.gov/study/NCT06112379
- TROPION-Breast04 design: https://doi.org/10.1177/17588359251316176

## Connected records

- cancers: [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cyclophosphamide](https://onco.cc/drugs/cyclophosphamide/), [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/), [Doxorubicin](https://onco.cc/drugs/doxorubicin/), [Durvalumab](https://onco.cc/drugs/durvalumab/), [Epirubicin](https://onco.cc/drugs/epirubicin/), [Olaparib](https://onco.cc/drugs/olaparib/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)

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