A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Phase 3 Active not recruiting 644 enrolled AstraZeneca Daiichi Sankyo · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

Timeline

Start: 2022-05-16
Primary completion: 2025-08-25
Completion: 2026-12-31

Outcome

Met primary endpoint

release “TROPION-Breast02 Phase III trial where AstraZeneca and Daiichi Sankyo’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints” astrazeneca.com ↗

Publications

Dent RA, Cescon DW, Bachelot T, Jung KH, Shao ZM, Saji S, Traina TA, Vukovic P, Mapiye D, Maxwell MJ, Schmid P, Cortes J. TROPION-Breast02: Datopotamab deruxtecan for locally recurrent inoperable or metastatic triple-negative breast cancer. Future Oncol. 2023 Nov;19(35):2349-2359. doi: 10.2217/fon-2023-0228. Epub 2023 Aug 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	—	Oral
Comparator	Carboplatin	Small molecule	—	Intravenous
Subject	Datopotamab deruxtecan	Monoclonal antibody	6 mg/kg	Intravenous
Comparator	Eribulin	Small molecule	—	Intravenous
Comparator	Nab-paclitaxel	Small molecule	—	Intravenous
Comparator	Paclitaxel	Small molecule	—	Intravenous