NCT05866432

Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.

Detailed description

Datopotamab-deruxtecan will be administered at a dose of 6.0 mg/kg body weight i.v. on day 1 once every three weeks in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases. Response rate by RANO-BM criteria is definied as primary endpoint.

Conditions

• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Datopotamab deruxtecan	Will be given until PD or withdraw

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-05-23
• Completion: 2026-05-23
• First posted: 2023-05-19
• Last updated: 2025-09-25

Locations

1 site across 1 country: Austria