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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Operable, non-metastatic breast cancer

Unwillingness to provide additional blood draws

Trial design

Treatments tested in this trial

  • T-DXd toxicity marker identification

Treatment groups

84 Participants
are divided into 1 treatment group

Sponsors and collaborators