Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer
Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
European Institute of Oncology
84 participants
Jul 31, 2025
OBSERVATIONAL
Conditions
Summary
the anti-Human Epidermal Growth Factor Receptor 2 (HER2) Trastuzumab-Deruxtecan (T-DXd) has shown impressive clinical activity in pretreated patients with metastatic breast cancer (MBC) but is also associated with a non-negligible rate of adverse events that may lead to treatment discontinuation and/or the onset of pneumonitis/interstitial lung disease (ILD) The aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities
Eligibility
Inclusion Criteria4
- Male or female, aged at least 18 years.
- Histologically documented invasive breast cancer, either HER2-positive or HER2-low/ultralow.
- Candidate to receive T-DXd as per standard practice.
- Consent for the provision of blood samples for exploratory analyses.
Exclusion Criteria2
- Operable, non-metastatic breast cancer
- Unwillingness to provide additional blood draws
Interventions
to find potential predictive markers associated with T-DXd-related toxicities
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07049133