Toxicity markers for Trastuzumab‑Deruxtecan in advanced breast cancer
Official title: Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
Run by European Institute of Oncology · NCT07049133 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | Trastuzumab |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | July 31, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT07049133 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.