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Brief Title: Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
Official Title: A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd Followed by THP Compared to ddAC-THP in Participants With High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)
Study ID: NCT05113251
Brief Summary: This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
Detailed Description: The target population of interest in this study is participants with high-risk HER2-positive early-stage breast cancer. The purpose of this study is to determine the efficacy and safety of T-DXd neoadjuvant therapy. Participants will be randomised to one of 3 arms: T-DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Springdale, Arkansas, United States
Research Site, Beverly Hills, California, United States
Research Site, Glendale, California, United States
Research Site, Los Alamitos, California, United States
Research Site, Orange, California, United States
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Research Site, Ogden, Utah, United States
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Research Site, Goiânia, , Brazil
Research Site, Ijuí, , Brazil
Research Site, Natal, , Brazil
Research Site, Porto Alegre, , Brazil
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Research Site, São Paulo, , Brazil
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Research Site, Panagyurishte, , Bulgaria
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Research Site, Edmonton, Alberta, Canada
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Research Site, Quebec City, Quebec, Canada
Research Site, Sherbrooke, Quebec, Canada
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Research Site, Beijing, , China
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Research Site, Raipur, , India
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Research Site, Thiruvananthapuram, , India
Research Site, Bologna, , Italy
Research Site, Candiolo, , Italy
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Research Site, Chuo-ku, , Japan
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Research Site, Hidaka-shi, , Japan
Research Site, Hiroshima-shi, , Japan
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Research Site, Goyang-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
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Research Site, Lima, , Peru
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Research Site, Taipei 112, , Taiwan
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