# TROPION-Breast02

Source: https://onco.cc/trials/tropion-breast02/  
OnCo record `tropion-breast02` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first trial to show an overall survival benefit for a first-line ADC in triple-negative breast cancer.

## Summary

TROPION-Breast02 randomized 644 patients (323/321) with previously untreated advanced TNBC for whom PD-1/PD-L1 inhibitor therapy was unsuitable. FDA reports median PFS 10.8 versus 5.6 months (HR 0.57, 95% CI 0.47 to 0.69) and OS 23.7 versus 18.7 months (HR 0.79, 95% CI 0.64 to 0.98). FDA approved the advanced-disease indication May 22, 2026. These outcomes do not establish postoperative benefit or provide a head-to-head comparison against sacituzumab govitecan.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-10-06
- Registry id: NCT05374512
- Phase: 3
- Setting: First-line metastatic TNBC, not candidates for PD-1/PD-L1: Dato-DXd vs chemotherapy
- Sponsor: AstraZeneca / Daiichi Sankyo
- Enrolled: 644
- Result: TROPION-Breast02 randomized 644 patients (323/321) with previously untreated advanced TNBC for whom PD-1/PD-L1 inhibitor therapy was unsuitable. FDA reports median PFS 10.8 versus 5.6 months (HR 0.57, 95% CI 0.47 to 0.69) and OS 23.7 versus 18.7 months (HR 0.79, 95% CI 0.64 to 0.98). FDA approved the advanced-disease indication May 22, 2026. These outcomes do not establish postoperative benefit or provide a head-to-head comparison against sacituzumab govitecan.
- Outcomes: Progression-free survival (BICR): Datopotamab deruxtecan 10.8 months vs Chemotherapy 5.6 months, HR 0.57; Overall survival: Datopotamab deruxtecan 23.7 months vs Chemotherapy 18.7 months, HR 0.79; Confirmed objective response rate (FDA approval analysis): Datopotamab deruxtecan 64% vs Chemotherapy 30%
- Replication: FDA-supporting advanced-disease randomized trial; postoperative benefit is not established.

## Notes

- Primary paper (Annals of Oncology 2026): 644 patients randomised 1 to 1 between May 2022 and June 2024, 90 percent PD-L1-negative, 10 percent with stable brain metastases; progression-free survival 10.8 versus 5.6 months (hazard ratio 0.57), overall survival 23.7 versus 18.7 months (hazard ratio 0.79, p 0.029); treatment-related grade 3 or higher adverse events 33 versus 29 percent, no treatment-related deaths. The chemotherapy arm was nab-paclitaxel 54 percent, paclitaxel 28 percent, eribulin 11 percent, carboplatin 4.7 percent, capecitabine 2.2 percent (Datroway label). UK sites (registry, 9): Bristol, Cardiff, Edinburgh, London (3), Northampton, Nottingham, Warwick. NICE appraisal GID-TA11535 awaiting development; no EU triple-negative indication yet.

## Sources

- FDA approval and randomized efficacy results: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer
- TROPION-Breast02 (Annals of Oncology 2026): https://doi.org/10.1016/j.annonc.2026.03.008
- Datroway label (openFDA): TROPION-Breast02 study section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22DATROWAY%22

## Connected records

- cancers: [HER2-low and HER2-ultralow metastatic breast cancer](https://onco.cc/cancers/her2-low-metastatic-breast-cancer/), [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/)
- drugs: [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/), [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)
- people: [Rebecca Dent](https://onco.cc/people/rebecca-dent/)
- key papers: [Breast Cancer, Version 4.2026, NCCN Clinical Practice Guidelines In Oncology](https://onco.cc/key-papers/paper-nccn-breast-cancer-v4-2026-jnccn-2026/), [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/), [TROPION-Breast01: datopotamab deruxtecan versus chemotherapy in pretreated hormone-receptor-positive breast cancer, and why a PFS win did not translate to survival](https://onco.cc/key-papers/paper-tropion-breast01-jco-2024/)
- 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: [A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-adc-sequencing-trial/), [TROP2 PET to choose and sequence TROP2 ADCs](https://onco.cc/ideas/idea-trop2-pet-selection/)
- 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/)
- institutions: [UCSF Helen Diller Family Comprehensive Cancer Center](https://onco.cc/institutions/ucsf/)

---
JSON: https://onco.cc/api/v1/entities/tropion-breast02.json