Toxicity markers for Trastuzumab‑Deruxtecan in advanced breast cancer
Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
This project will test whether blood markers can predict serious side effects, including interstitial lung disease, in adults with metastatic HER2‑positive or HER2‑low breast cancer who are treated with Trastuzumab‑Deruxtecan.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | Trastuzumab |
| Locations | 1 site (Milan) |
| Trial ID | NCT07049133 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational biomarker study enrolling adults with metastatic HER2‑positive or HER2‑low breast cancer who are planned to receive Trastuzumab‑Deruxtecan as part of routine care. Participants provide additional blood samples for exploratory analyses while clinical outcomes and toxicities are recorded. The main focus is to identify markers associated with any‑grade ILD/pneumonitis and with grade ≥3 toxicities related to T‑DXd. Findings will be correlated with treatment course and severity of adverse events to describe potentially predictive signatures.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed metastatic HER2‑positive or HER2‑low breast cancer who are candidates for Trastuzumab‑Deruxtecan and willing to provide blood samples are ideal for this project.
Not a fit: Patients with operable non‑metastatic breast cancer, those not receiving Trastuzumab‑Deruxtecan, or those unwilling or unable to give blood samples are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors identify patients at higher risk for serious T‑DXd toxicities so treatment can be personalized or monitoring intensified to prevent severe lung injury.
How similar studies have performed: Some smaller studies and case series have reported candidate risk factors and biomarkers for T‑DXd‑related ILD, but reliable, validated predictive markers have not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan
- European Institute of Oncolgy — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Elisabetta Munzone, MD — European Institute of Oncology
- Study coordinator: Elisabetta Munzone, MD
- Email: elisabetta.munzone@ieo.it
- Phone: +39 0257489405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.