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Study of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive primary breast cancer
THE MAIN OBJECTIVE OF THIS CLINICAL STUDY IS TO COLLECT INFORMATION ABOUT THE DRUG T-DXD.T-DXD IS AN ANTIBODY-DRUG CONJUGATE, WHICH MEANS THAT IT IS MADE UP OF 2 PARTS: A DRUG AND AN ANTIBODY (TYPE OF PROTEIN). THE ANTIBODY PART BINDS TO CANCER CELLS WITH HER2 AND DEPOSITS THE DRUG PART INTO THE CANCER CELL. THE GOAL OF THIS STUDY IS TO DETERMINE WHETHER T-DXD COULD BE EFFECTIVE IN TREATING HER2-POSITIVE EARLY BREAST CANCER IN PEOPLE WHO HAVE ALREADY BEEN TREATED BEFORE BREAST CANCER SURGERY, SPECIFICALLY IN PEOPLE WHO ARE CONSIDERED TO BE AT HIGH RISK FOR BREAST CANCER RECURRENCE.
Technical Summary
- PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL, OPEN-LABEL, CONTROLLED STUDY OF TRASTUZUMAB DERUXTECAN (T-DXD) VERSUS TRASTUZUMAB EMTANSINE (T-DM1) IN PATIENTS WITH HIGH-RISK HER2-POSITIVE PRIMARY BREAST CANCER WHO HAVE RESIDUAL INVASIVE DISEASE IN THE BREAST OR AXILLARY LYMPH NODES AFTER NEOADJUVANT TREATMENT. IMMUNOTHERAPY
- Code EudraCT: 2020-003982-20
- Protocol number: DS8201-A-U305
- Promoter: Daiichi Sankyo Development Ltd
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