Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer

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.

Timeline

Start

2023-10-26

Primary completion

2027-04-30

Completion

2032-04-30

Publications

• Matikas A, Naume B, Wildiers H, Sonke G, Dieci MV, Karakatsanis A, Andersson A, Barnekow E, Kessler LE, Einbeigi Z, Killander F, Linderholm B, Schiza A, Valachis A, Nearchou A, Engebraaten O, Porojnicu A, Soland MH, Mannsaker B, Raj SX, Blix ES, Nordstrand CS, Lambertini M, Vernieri C, Punie K, Sotiriou C, Bergh J, Villacampa G, Zouzos A, Hellstrom M, Hartman J, Foukakis T. Randomised trial of trastuzumab deruxtecan and biology-driven selection of neoadjuvant treatment for HER2-positive breast cancer: a study protocol of ARIADNE. BMJ Open. 2025 Aug 27;15(8):e102626. doi: 10.1136/bmjopen-2025-102626.

Drugs

Indications