NCT07049133

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 84 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
OTHER	T-DXd toxicity marker identification	to find potential predictive markers associated with T-DXd-related toxicities

Timeline

• Start date: 2025-07-31
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-07-03
• Last updated: 2026-01-06

Locations

1 site across 1 country: Italy