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Brief Title: Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer
Official Title: A Randomized Trial of Trastuzumab Deruxtecan and Biology-Driven Selection of Neoadjuvant Treatment for HER2-positive Breast Cancer: ARIADNE
Study ID: NCT05900206
Brief Summary: The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are: * is T-DXd more effective than standard preoperative treatment? * are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment? Participants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Skåne University Hospital, Malmö, , Sweden
Sankt Gorans Hospital, Stockholm, , Sweden
Stockholm Southern Hospital, Stockholm, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Norrlands University Hospital, Umeå, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
Örebro University Hospital, Örebro, , Sweden
Name: Theodoros Foukakis, MD/PhD
Affiliation: Karolinska University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Alexios Matikas, MD/PhD
Affiliation: Karolinska University Hospital
Role: PRINCIPAL_INVESTIGATOR