NCT04752059

Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases

Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases

Detailed description

T-DXd will be administered at a dose of 5.4 mg/kg body weight once every three weeks in patients with newly diagnosed or progressive HER2 positive breast cancer brain metastases. Response rate by RANO-BM is defined the primary study endpoint.

Conditions

• Breast Cancer Stage IV

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	Trastuzumab-deruxtecan 5.4 mg/kg body weight i.v. on day 1 once every three weeks until progression or death

Timeline

• Start date: 2020-07-28
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2021-02-12
• Last updated: 2023-05-12

Locations

1 site across 1 country: Austria