Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T-DXd toxicity marker identification | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2-positive or HER2- low/ultralow metastatic patient
- description
- Candidate to receive T-DXd as per standard practice for HER2-positive or HER2- low/ultralow advanced breast cancer.
- interventionNames
- Other: T-DXd toxicity marker identification
Primary outcomes (1)
- measure
- Comparison of mean levels of cytokine and T-DXd toxicity
- timeFrame
- 2 years
- description
- cytokine quantification in blood sample collected at baseline and before cycle 3 day 1
Secondary outcomes (2)
- measure
- Incidence of T-DXd Treatment Adverse Events
- timeFrame
- 2 years
- description
- Adverse event (AE) collection with particular focus on ILD/pneumonitis and any other Grade 3 (G3) AE
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available