NCT05374512

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)

Active, enrolled Phase 3 Last updated 27 January 2026

What this trial tests

Phase 3 trial testing Dato-DXd in Breast Cancer in 644 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 May 2022

Primary endpoint
25 August 2025

31 December 2026

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	644
Start date	16 May 2022
Primary completion	25 August 2025
Estimated completion	31 December 2026
Sites	228 locations across Belgium, Japan, Singapore, United States, South Africa, Italy, Philippines, Mexico

Drugs / interventions tested

• Dato-DXd — full drug profile →
• Paclitaxel — full drug profile →
• Nab-paclitaxel
• Carboplatin (Carboplatin) — full drug profile →
• Capecitabine (capecitabine) — full drug profile →
• Eribulin mesylate

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2023.
   Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, et al · · 2023 · cited 204× · PMID 36472472 · DOI 10.1080/19420862.2022.2153410
2. Recent advances in targeted strategies for triple-negative breast cancer.
   Zhu S, Wu Y, Song B, Yi M, et al · · 2023 · cited 200× · PMID 37641116 · DOI 10.1186/s13045-023-01497-3
3. Modulation of the tumor microenvironment and mechanism of immunotherapy-based drug resistance in breast cancer.
   Kundu M, Butti R, Panda VK, Malhotra D, et al · · 2024 · cited 121× · PMID 38715072 · DOI 10.1186/s12943-024-01990-4
4. Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2- and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study.
   Bardia A, Krop IE, Kogawa T, Juric D, et al · · 2024 · cited 111× · PMID 38652877 · DOI 10.1200/jco.23.01909
5. Antibody-Drug Conjugates (ADCs): current and future biopharmaceuticals.
   Wang R, Hu B, Pan Z, Mo C, et al · · 2025 · cited 105× · PMID 40307936 · DOI 10.1186/s13045-025-01704-3
6. Antibody-drug conjugates targeting TROP-2: Clinical development in metastatic breast cancer.
   Shastry M, Jacob S, Rugo HS, Hamilton E. · · 2022 · cited 104× · PMID 36302269 · DOI 10.1016/j.breast.2022.10.007
7. Trop-2 as a Therapeutic Target in Breast Cancer.
   Sakach E, Sacks R, Kalinsky K. · · 2022 · cited 64× · PMID 36497418 · DOI 10.3390/cancers14235936
8. Trial watch: chemotherapy-induced immunogenic cell death in oncology.
   Sprooten J, Laureano RS, Vanmeerbeek I, Govaerts J, et al · · 2023 · cited 59× · PMID 37284695 · DOI 10.1080/2162402x.2023.2219591