NCT07049133Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 84 (estimated)
- First submitted
- 25 Jun 2025
- Start date
- 31 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- European Institute of Oncology
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07049133
What you commit to
- Study type: Observational
- Planned participants: 84
- From 31 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Operable, non-metastatic breast cancer
Other
- Unwillingness to provide additional blood draws
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| European Institute of Oncolgy Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.