Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, Trastuzumab-Deruxtecan, ILD/pulmonitis
Brief 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
Detailed description
Despite advanced in diagnosis and in the treatment management, advanced breast cancer (ABC) is still an incurable disease. Recent pharmaceutical developments have changed treatment algorithms in MBC and have further improved the overall prognosis of patients which exploit the tumor-targeting activity of monoclonal antibodies to deliver at the tumor site potent chemotherapeutic agents that would otherwise be exceedingly toxic if delivered systemically. Among them, new effective anticancer drugs, such as Trastuzumab-Deruxtecan (T-DXd), have revolutionized the clinical management of HER2-positive and HER2-low ABC. However, this drug is associated with a non-negligible rate of adverse events that can lead to treatment discontinuation and/or the onset of pneumonitis/interstitial lung disease (ILD), a potentially fatal adverse event. The aim of the study is to identify and describe potentially predictive markers related to the onset of relevant T-DXd-related toxicities (both any grade ILD/pneumonitis and any toxicity of grade ≥3) in a population of patients treated with T-DXd according to standard clinical practice.
Interventions
OTHERT-DXd toxicity marker identification
to find potential predictive markers associated with T-DXd-related toxicities
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of mean levels of cytokine and T-DXd toxicity | 2 years | cytokine quantification in blood sample collected at baseline and before cycle 3 day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of T-DXd Treatment Adverse Events | 2 years | Adverse event (AE) collection with particular focus on ILD/pneumonitis and any other Grade 3 (G3) AE |
| T-DXd activity evaluation | 8 months | collection of tumor assessment data during T-DXd therapy |
Countries
Italy
Contacts
Primary ContactElisabetta Munzone, MD
Backup ContactDavide Merli, PHD
Outcome results
None listed