Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-01-01 @ 4:21 AM
Study NCT ID:
NCT07049133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer
Sponsor:
European Institute of Oncology
Organization:
Study Overview
Official Title:
Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tox-DXd
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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UID4972 | OTHER | Clinical Trial Office - Istituto Europeo di oncologia | View |