Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer

Recruiting now

Conditions studied: Metastatic Breast Cancer

In brief

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

Key facts

Study ID

NCT07049133

Run by

European Institute of Oncology

People needed

84

Starts

2025-07-31

Expected to finish

2027-12-31

Last updated by the study team

2026-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Operable, non-metastatic breast cancer
• Unwillingness to provide additional blood draws

Where it is running

• European Institute of Oncolgy — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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