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Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
European Institute of Oncolgy
RECRUITING
Milan
Contact Information
Primary
Elisabetta Munzone, MD
elisabetta.munzone@ieo.it
+39 0257489405
Backup
Davide Merli, PHD
davide.merli@ieo.it
+39 0294372213
Time Frame
Start Date: 2025-07-31
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 84
Treatments
HER2-positive or HER2- low/ultralow metastatic patient
Candidate to receive T-DXd as per standard practice for HER2-positive or HER2- low/ultralow advanced breast cancer.
Related Therapeutic Areas
Sponsors
Leads: European Institute of Oncology

This content was sourced from clinicaltrials.gov

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