NCT06112379

A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,902 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Detailed description

The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by investigator assessment of EFS.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Dato-DXd	Experimental drug IV infusion
DRUG	Durvalumab	Experimental drug IV Infusion
DRUG	Pembrolizumab	IV Infusion Active comparator
DRUG	Doxorubicin	IV infusion Experimental/Active Comparator
DRUG	Epirubicin	IV Infusion Experimental/Active Comparator
DRUG	Cyclophosphamide	IV infusion Experimental/Active Comparator
DRUG	Paclitaxel	IV infusion Experimental/Active Comparator
DRUG	Carboplatin	IV infusion Experimental/Active Comparator
DRUG	Capecitabine	Tablet Oral route of administration Experimental/Active Comparator
DRUG	Olaparib	Tablet Oral route of administration Experimental/Active Comparator

Timeline

• Start date: 2023-11-14
• Primary completion: 2028-11-20
• Completion: 2032-09-23
• First posted: 2023-11-01
• Last updated: 2026-04-02

Locations

283 sites across 26 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Malaysia, Poland, Singapore, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study