A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
Sponsor: AstraZeneca
A observational or N/A phase clinical study on Breast Cancer, this trial is actively recruiting participants. The trial is conducted by AstraZeneca and has accumulated 19 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI \> 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no).
This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.
The primary objective of the study is to demonstrate superiority of Dato-DXd + durvalumab relative to ICC + pembrolizumab by assessment of PFS as assessed by BICR in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
The study will be stratified based on geographic location (US/Canada/Europe vs. Dato-DXd monotherapy enrolling countries vs. rest of world), disease-free interval (DFI) history (de novo vs. prior DFI 6 to 12 months vs. prior DFI \> 12 months), and prior PD-1/PD-L1 treatment for early stage TNBC (yes vs. no).
This study aims to see if Dato-DXd with durvalumab allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy and pembrolizumab. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.
Status Flow
Change History
19 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
-
Feb 2026 — May 2026 [monthly]
Recruiting PHASE3
-
Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE3
-
Oct 2025 — Dec 2025 [monthly]
Recruiting PHASE3
-
Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE3
▶ Show 14 earlier versions
-
May 2025 — Sep 2025 [monthly]
Recruiting PHASE3
-
Dec 2024 — May 2025 [monthly]
Recruiting PHASE3
-
Nov 2024 — Dec 2024 [monthly]
Recruiting PHASE3
-
Oct 2024 — Nov 2024 [monthly]
Recruiting PHASE3
-
Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE3
-
Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE3
-
Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE3
-
Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE3
-
May 2024 — Jun 2024 [monthly]
Recruiting PHASE3
-
Apr 2024 — May 2024 [monthly]
Recruiting PHASE3
-
Mar 2024 — Apr 2024 [monthly]
Recruiting PHASE3
-
Feb 2024 — Mar 2024 [monthly]
Recruiting PHASE3
-
Dec 2023 — Feb 2024 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
-
Nov 2023 — Dec 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.
Contact Information
- AstraZeneca
- Daiichi Sankyo
For direct contact, visit the study record on ClinicalTrials.gov .