Clinical Trial

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

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated August 5, 2024 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-01-24; most recent amendment 2024-08-02.
Status change: Recruiting → Active, Not Recruiting 2024-08-02
Status change: Not Yet Recruiting → Recruiting 2023-11-24
Trial Details
NCT Number NCT05710666
Lead Sponsor Cancer Trials Ireland
Conditions HER2-positive Breast Cancer
Enrollment 11 participants
Start Date 2023-10-26
Primary Completion 2025-09-30 (estimated)
Study Completion 2028-03-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-05