Cancer Trials Ireland
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.
HER2-positive Breast Cancer
trastuzumab deruxtecan (T-DXd) (IV)
Phase 2
In this single arm Phase 2 trial we will administer T-DXd 5.4mg/kg intravenously every three weeks for up to six cycles. A mandatory repeat biopsy at Cycle 2 Day 14 +/- 4 days of starting T-DXd will be performed for the RNA Disruption Index (RDI) score assessment. As a safety measure patients will undergo clinical examination before each cycle of T-DXd to enable early identification of on-treatment locoregional progression. If progression is seen then T-DXd will be stopped and the patient will be taken off study treatment. In the absence of early progression, those patients with a high chance of pathological complete response (pCR) based on the RDI score will undergo repeat breast imaging after four cycles of T-DXd. Patients who have a high chance of pCR based on the RDI score will proceed to surgery after four cycles of T-DXd if they also have imaging complete response (iCR) at that point. Other patients who have a high chance of pCR based on the RDI score but iCR is not attained after four cycles or who have a low/intermediate chance of pCR based on the RDI score will undergo repeat breast imaging after six cycles of T-DXd. Patients with iCR after six cycles of T-DXd regardless of RDI score will proceed to surgery. Patients who have a low/intermediate chance of pCR based on the RDI score and residual disease on imaging after six cycles of T-DXd will undergo either further systemic therapy or proceed to surgery (at the discretion of their treating physician). Based on the surgical specimen, patients who achieve a pCR will undergo further trastuzumab post-operatively to complete a total of 52 weeks of systemic therapy from the first cycle of T-DXd. Patients with residual disease at surgery will receive adjuvant chemotherapy as decided by the treating physician.
Study Type : | Interventional |
Estimated Enrollment : | 80 participants |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Single Arm Phase 2 Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer: a Standard Chemotherapy-sparing Approach to Curative-intent Treatment - SHAMROCK Study |
Actual Study Start Date : | October 26, 2023 |
Estimated Primary Completion Date : | September 30, 2025 |
Estimated Study Completion Date : | March 30, 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: T-DXd |
Drug: trastuzumab deruxtecan (T-DXd) (IV) |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
University Hospital Galway
Galway, Connaught, Ireland, D4
Not yet recruiting
Saint Vincent's University Hospital
Dublin, Leinster, Ireland, D9
Recruiting
Beaumont Hospital
Dublin, Leinster, Ireland,
Not yet recruiting
Cork University Hospital
Cork, Munster, Ireland,
Not yet recruiting
University Hospital Limerick
Limerick, Munster, Ireland,