SHAMROCK study

About this trial

This study is a single arm Phase 2 clinical trial where patients before their definitive surgery will be treated with trastuzumab deruxtecan (T-DXd) 5.4mg/kg intravenously every three weeks for up to six cycles. A mandatory biopsy at Cycle 2 Day 14 (+/- 4 days) of starting T-DXd will be performed for the RNA Disruption Index (RDI) score assessment that will be used to predict an effectiveness of study treatment. Depending on the RDI score results some patients will have imaging assessments performed at the end of Cycle 4 and if scans will show absence of remaining tumour they will stop study treatment and proceed to surgery after four cycles of treatment. Other patients will continue treatment until six cycles are completed.

Patient Profile

Patient with newly diagnosed early stage HER2-positive breast cancer with tumour size larger than 2cm

Where’s this trial being run?

Beaumont Hospital, Cork University Hospital, St James’s Hospital, St Vincents University Hospital, and University Hospital Limerick

Can I join this study / trial?

The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.

It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.

For more detailed information

Click Here

Questions?

Here’s a list of questions you may have for your doctor or local cancer research team.

Questions

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Summary Data

Name:	SHAMROCK study
Number:	22-01
Full 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

Principal Investigator:	Prof. Bryan Hennessy
Type:	In-House
Sponsor:	Cancer Trials Ireland
Recruitment Started:	Global: 26-Oct-2023 Ireland: 26-Oct-2023

Global Recruitment Target:	80
Ireland Recruitment Target:	80