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
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.
Operable, non-metastatic breast cancer
Unwillingness to provide additional blood draws
male or female advanced breast cancer patient, either HER2-positive or HER2-low/ultralow, candidate to receive T-DXd as per standard practice
Cohort
Prospective
T-DXd toxicity marker identification
Other interventionto find potential predictive markers associated with T-DXd-related toxicities
Comparison of mean levels of cytokine and T-DXd toxicity
cytokine quantification in blood sample collected at baseline and before cycle 3 day 1
Incidence of T-DXd Treatment Adverse Events
Adverse event (AE) collection with particular focus on ILD/pneumonitis and any other Grade 3 (G3) AE
T-DXd activity evaluation
collection of tumor assessment data during T-DXd therapy
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