T-DXd control arm Real World Evidence HER2 Tissue Testing Project
Research type
Research Study
Full title
T-DXd Pan-tumor EC study. External Control Arm Study to Support HTA Submissions for T-DXd for Patients with HER2 IHC3+ Solid Tumors.
IRAS ID
353348
Contact name
Nicolas Orsi
Contact email
Sponsor organisation
AstraZeneca
Clinicaltrials.gov Identifier
25/PR/0343,
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The AstraZeneca Destiny studies looked at the use of the anti-cancer agent Trastuzumab deruxtecan (T-DXd) across a broad array of cancer types. T-DXd is a drug which targets and delivers chemotherapy to the HER2 receptor. The HER2 receptor is commonly expressed in breast and stomach cancers and HER2 targeted drugs are in routine use in these malignancies. The Destiny studies enrolled patients with a broad range of cancer types, not typically treated with HER2 targeted therapies, tested their tissue samples for HER2 status and treated them with T-DXd. The results of these studies have been published and suggest anti-cancer activity with T-DXd along with improved outcomes, especially in those tumours which had a HER2 result of 3+ on immunohistochemical testing. The Destiny studies were multicentre, multinational studies but were single arm i.e. did not have a control arm within the study. This study is to provide a real world evidence comparator study arm for the previous Destiny studies.
REC name
London - Surrey Research Ethics Committee
REC reference
25/PR/0343
Date of REC Opinion
4 Apr 2025
REC opinion
Favourable Opinion