Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer
Recruiting · NCT07049133 · Observational (researchers observe without assigning treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
T-DXd toxicity marker identification
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- Operable, non-metastatic breast cancer
- Unwillingness to provide additional blood draws
Where it is running
1 location listed.
- European Institute of Oncolgy - Milan, Italy