Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study)

Summary

This study is a Phase 2 open label, single arm, adaptive multi-centre trial. Patients with early stage HER2-positive breast cancer will receive neoadjuvant treatment of trastuzumab deruxtecan (T-DXd) 5.4mg/kg intravenously every three weeks for up to six cycles.

Timeline

Start

2023-10-26

Primary completion

2025-09-30

Completion

2028-03-30

Publications

• Dowling GP, Toomey S, Bredin P, Parker I, Mulroe E, Marron J, McLoughlin O, Teiserskiene A, Power C, O'Shea AM, Greally M, Morris PG, Duke D, Hill ADK, Hennessy BT. Neoadjuvant trastuzumab deruxtecan (T-DXd) with response-directed definitive therapy in early stage HER2-positive breast cancer: a phase II study protocol (SHAMROCK study). BMC Cancer. 2024 Jan 17;24(1):91. doi: 10.1186/s12885-024-11851-4.

Drugs

Indications