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

Sponsor
Cancer Trials Ireland
Study ID
NCT05710666
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • trastuzumab deruxtecan (T-DXd) (IV) — DRUG
    Administered as an intravenous (IV) infusion at a dose of 5.4 mg/kg on Day 1 of each 21-day cycle for up to six cycles.

Study Details

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.

Key Dates

Start date
Oct 26, 2023
Status verified
Aug 2024
Primary completion
Sep 30, 2025
Completion
Mar 30, 2028

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: T-DXd

Primary Outcome Measure

The percentage of patients who achieve pCR after T-DXd treatment [ Time Frame: From registration until surgery, approximately 18 weeks ]

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