Active Not Recruiting PHASE3 INTERVENTIONAL 2-arm 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)

A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02)

Sponsor: AstraZeneca

Conditions Breast Cancer

Interventions Capecitabine Carboplatin Dato-DXd Eribulin mesylate Nab-paclitaxel Paclitaxel

Updated 29 times since 2022 Last updated: Jan 26, 2026 Started: May 16, 2022 Primary completion: Aug 25, 2025 Completion: Nov 3, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Breast Cancer and is currently ongoing. AstraZeneca leads this study, which shows 29 recorded versions since 2022 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

29 versions recorded

Feb 2026 — Present [monthly]

Active Not Recruiting PHASE3
Dec 2025 — Feb 2026 [monthly]

Active Not Recruiting PHASE3
Oct 2025 — Dec 2025 [monthly]

Active Not Recruiting PHASE3
Sep 2025 — Oct 2025 [monthly]

Active Not Recruiting PHASE3
Aug 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE3

▶ Show 24 earlier versions

May 2025 — Aug 2025 [monthly]

Active Not Recruiting PHASE3
Feb 2025 — May 2025 [monthly]

Active Not Recruiting PHASE3
Sep 2024 — Feb 2025 [monthly]

Active Not Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3
Apr 2024 — Jul 2024 [monthly]

Recruiting PHASE3
Mar 2024 — Apr 2024 [monthly]

Recruiting PHASE3
Feb 2024 — Mar 2024 [monthly]

Recruiting PHASE3
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE3
Dec 2023 — Jan 2024 [monthly]

Recruiting PHASE3
Nov 2023 — Dec 2023 [monthly]

Recruiting PHASE3
Oct 2023 — Nov 2023 [monthly]

Recruiting PHASE3
Aug 2023 — Oct 2023 [monthly]

Recruiting PHASE3
Jun 2023 — Aug 2023 [monthly]

Recruiting PHASE3
May 2023 — Jun 2023 [monthly]

Recruiting PHASE3
Mar 2023 — May 2023 [monthly]

Recruiting PHASE3
Feb 2023 — Mar 2023 [monthly]

Recruiting PHASE3
Jan 2023 — Feb 2023 [monthly]

Recruiting PHASE3
Dec 2022 — Jan 2023 [monthly]

Recruiting PHASE3
Nov 2022 — Dec 2022 [monthly]

Recruiting PHASE3
Oct 2022 — Nov 2022 [monthly]

Recruiting PHASE3
Sep 2022 — Oct 2022 [monthly]

Recruiting PHASE3
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE3
Jun 2022 — Jul 2022 [monthly]

Recruiting PHASE3

First recorded

May 2022

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AstraZeneca
Daiichi Sankyo

Data source: AstraZeneca

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Anderlecht, Belgium , Ankara, Turkey (Türkiye) , Aschaffenburg, Germany , Atlanta, United States , Bacolod, Philippines , Bangalore, India , Bangkok, Thailand , Barcelona, Spain , Barrie, Canada and 179 more locations