About this trial
This study will examine trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary BC who have residual invasive disease in breast or axillary lymph nodes with higher risk of recurrence, which includes patients who were inoperable at disease presentation or had pathological node-positive status after neoadjuvant therapy.
The primary objective is to compare invasive disease-free survival (IDFS) between T-DXd and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS).
Patients with HER2-positive primary breast cancer who do not achieve complete response after appropriate neoadjuvant therapy and are at higher risk of disease recurrence.
Where’s this trial being run?
Cork University Hospital, St James’s Hospital, St Vincents University Hospital, University Hospital Limerick, and Mater Misericordiae University Hospital
Can I join this study / trial?
The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.
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Here’s a list of questions you may have for your doctor or local cancer research team.Questions
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)
|Principal Investigator:||Prof Janice Walshe (St. Vincent’s University Hospital)|
Daiichi Sankyo, Inc.
Global: Dec 2020
Ireland: Aug 2021
|Global Recruitment Target:||1600|
|Ireland Recruitment Target:||5|