NCT06103864

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 625 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Dato-DXd	Provided in 100mg vials. IV infusion. Experimental drug.
DRUG	Durvalumab	Provided in 500mg vials. IV infusion. Experimental drug.
DRUG	Paclitaxel	IV infusion. Active comparator.
DRUG	Nab-paclitaxel	IV infusion. Active comparator.
DRUG	Gemcitabine	IV infusion. Active comparator.
DRUG	Carboplatin	IV infusion. Active comparator.
DRUG	Pembrolizumab	IV infusion. Active comparator.

Timeline

• Start date: 2023-11-23
• Primary completion: 2027-07-28
• Completion: 2030-09-30
• First posted: 2023-10-27
• Last updated: 2026-03-31

Locations

316 sites across 24 countries: United States, Argentina, Australia, Brazil, Canada, China, France, Germany, Hong Kong, India, Italy, Japan, Mexico, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study