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Brief Title: Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Official Title: Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Study ID: NCT05866432
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
AKH Universitaetsklinikum Vienna, Department f. Internal medicine I, oncology, Vienna, , Austria
Name: Rupert Rupert, MD
Affiliation: Medical University Vienna
Role: PRINCIPAL_INVESTIGATOR