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Phase IIIb, multicenter, global, interventional, open-label, global, interventional, phase IIIb study of trastuzumab deruxtecan (T-DXd), an anti-HER2 antibody-drug conjugate (CAF), in subjects with unresectable and/or metastatic HER2-low or HER2 immunohistochemically (IHQ) 0 unresectable and/or metastatic breast cancer (BC)
THE PURPOSE OF THIS STUDY IS TO INVESTIGATE AN INVESTIGATIONAL DRUG CALLED TRASTUZUMAB DERUXTECAN (T-DXD). AN INVESTIGATIONAL DRUG IS A DRUG THAT IS BEING STUDIED TO SEE IF IT IS SAFE AND TO SEE IF YOUR DISEASE OR MEDICAL CONDITION IMPROVES WHILE YOU ARE TAKING IT.
Technical Summary
- PHASE IIIB, MULTICENTER, GLOBAL, INTERVENTIONAL, OPEN-LABEL, GLOBAL, INTERVENTIONAL, PHASE IIIB STUDY OF TRASTUZUMAB DERUXTECAN (T-DXD), AN ANTI-HER2 ANTIBODY-DRUG CONJUGATE (CAF), IN SUBJECTS WITH UNRESECTABLE AND/OR METASTATIC HER2-LOW OR HER2 IMMUNOHISTOCHEMICALLY (IHQ) 0 UNRESECTABLE AND/OR METASTATIC BREAST CANCER (BC)
- Code EudraCT: 2023-505616-38-00
- Protocol number: DS8201-0001-CIS-MA
- Promoter: Daiichi Sankyo Development Ltd
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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