# TROPION-Breast05

Source: https://onco.cc/trials/tropion-breast05/  
OnCo record `tropion-breast05` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Tests whether Dato-DXd plus a PD-L1 blocker beats today's immunotherapy-chemotherapy standard.

## Summary

TROPION-Breast05 compares datopotamab deruxtecan with or without durvalumab against chemotherapy plus pembrolizumab in previously untreated PD-L1-positive advanced TNBC. The primary PFS comparison is datopotamab deruxtecan plus durvalumab against chemotherapy plus pembrolizumab. ClinicalTrials.gov record last updated 2026-09-25: recruiting. Enrollment is planned at 625 participants. Primary completion is estimated at 2027-07-28. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-10-06
- Registry id: NCT06103864
- Phase: 3
- Setting: A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
- Sponsor: AstraZeneca / Daiichi Sankyo
- Enrolled: 625
- Replication: Ongoing; no results.

## Notes

- ClinicalTrials.gov record last updated 2026-09-25: recruiting. Enrollment is planned at 625 participants. Primary completion is estimated at 2027-07-28. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.
- Design paper (Therapeutic Advances in Medical Oncology 2025): 625 patients with PD-L1-high (CPS 10 or more) disease randomised 1 to 1 to datopotamab deruxtecan 6 mg/kg with durvalumab 1,120 mg every 3 weeks or investigator's choice chemotherapy with pembrolizumab, with a third datopotamab-alone arm in selected countries; primary endpoint progression-free survival by blinded review; primary completion July 2027. UK sites (registry, 10): Cardiff, Chelsea, Leicester, Liverpool, London (2), Oxford, Surrey, Sutton, Taunton.

## Sources

- ClinicalTrials.gov NCT06103864: https://clinicaltrials.gov/study/NCT06103864
- TROPION-Breast05 design: https://doi.org/10.1177/17588359251327992

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- drugs: [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/), [Durvalumab](https://onco.cc/drugs/durvalumab/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- key papers: [Datopotamab deruxtecan in patients with untreated, advanced triple-negative breast cancer (TROPION-Breast02): a randomised, open-label, international, phase III trial](https://onco.cc/key-papers/paper-tropion-breast02-ann-oncol-2026/)
- roadmaps: [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/), [TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET](https://onco.cc/roadmaps/trop2-adc-roadmap/)
- ideas: [Trials that include, and report, brain metastases in triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-brain-metastasis-trials/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)
- trials: [DIAMOND](https://onco.cc/trials/diamond/), [KEYNOTE-355](https://onco.cc/trials/keynote-355/)
- pairings: [ADC + checkpoint inhibitor](https://onco.cc/pairings/adc-plus-io/)

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