# TROPION-Breast03

Source: https://onco.cc/trials/tropion-breast03/  
OnCo record `tropion-breast03` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Tests whether an experimental drug, with or without immunotherapy, helps prevent recurrence after residual triple-negative breast cancer is removed at surgery.

## Summary

TROPION-Breast03 compares datopotamab deruxtecan plus durvalumab, datopotamab deruxtecan alone, and investigator choice of capecitabine, pembrolizumab or both after surgery for stage I to III TNBC with residual invasive disease following neoadjuvant treatment. The registered primary iDFS comparison is the datopotamab deruxtecan plus durvalumab arm against investigator choice. ClinicalTrials.gov record last updated 2026-06-15: active not recruiting. Enrollment is actual at 1174 participants. Primary completion is estimated at 2027-09-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-10-06
- Registry id: NCT05629585
- Phase: 3
- Setting: A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
- Sponsor: AstraZeneca / Daiichi Sankyo
- Enrolled: 1174
- Replication: Ongoing; no results.

## Notes

- ClinicalTrials.gov record last updated 2026-06-15: active not recruiting. Enrollment is actual at 1174 participants. Primary completion is estimated at 2027-09-20. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.
- Design paper (Therapeutic Advances in Medical Oncology 2024): stage I to III triple-negative disease with residual invasive disease at surgery, randomised 2 to 1 to 2 to datopotamab deruxtecan 6 mg/kg for eight cycles with durvalumab for nine, datopotamab alone, or investigator's choice of capecitabine, pembrolizumab or both; primary endpoint invasive disease-free survival for the combination against investigator's choice; registry 1,174 actual, primary completion September 2027. UK sites (registry, 12): Cambridge, Cardiff, Edinburgh, Greater London, London (2), Londonderry, Manchester, Newcastle upon Tyne, Portsmouth, Surrey, Taunton. NICE appraisal GID-TA11835 awaiting development.

## Sources

- ClinicalTrials.gov NCT05629585: https://clinicaltrials.gov/study/NCT05629585
- TROPION-Breast03 design (Ther Adv Med Oncol 2024): https://journals.sagepub.com/doi/10.1177/17588359241248336
- TROPION-Breast03 design: https://doi.org/10.1177/17588359241248336

## Connected records

- ideas: [ADC for residual disease after KEYNOTE-522](https://onco.cc/ideas/idea-post-neoadjuvant-adc/), [ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative](https://onco.cc/ideas/idea-tnbc-ctdna-guided-adjuvant-decisions/)
- trials: [ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)](https://onco.cc/trials/ascent-05/), [CREATE-X](https://onco.cc/trials/create-x/), [KEYNOTE-522](https://onco.cc/trials/keynote-522/)
- cancers: [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: [Capecitabine](https://onco.cc/drugs/capecitabine/), [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/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/), [Residual cancer burden (RCB)](https://onco.cc/terms/rcb/), [Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point](https://onco.cc/terms/tnbc-residual-disease-decision/), [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)
- key papers: [Long-Term Prognostic Risk After Neoadjuvant Chemotherapy Associated With Residual Cancer Burden and Breast Cancer Subtype](https://onco.cc/key-papers/paper-symmans-rcb-long-term-prognosis-subtype-jco-2017/)
- roadmaps: [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/)

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