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Brief Title: Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases
Official Title: Phase II Study of Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Study ID: NCT04752059
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
AKH Universitaetsklinikum Vienna, Department f. Internal medicine I, oncology, Vienna, , Austria
Name: Rupert Bartsch, MD
Affiliation: Medical University of Vienna
Role: PRINCIPAL_INVESTIGATOR