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

RECRUITINGSponsored by European Institute of Oncology
Actively Recruiting
SponsorEuropean Institute of Oncology
Started2025-07-31
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07049133

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Breast CancerCancerMetastatic Breast Cancer

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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