Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / NCT07049133
Recruiting Observational

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

NCT07049133 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Observational
Started
2025-07-31
Last updated
2026-01-06

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

T-DXd toxicity marker identification

T-DXd toxicity marker identification: to find potential predictive markers associated with T-DXd-related toxicities

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncolgy Milan Italy Recruiting

More European Institute of Oncology trials in Italy

MONDRIAN: Multi-omics Integrative Modelling for Stereotactic Body Radiotherapy in Early-stage Non-small Cell Lung Cancer Recruiting
YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. Recruiting
A New Tool to Promote Patient's Engagement in Their Healthcare Process Recruiting
Cognitive Impairment Assessment in Breast Cancer Survivors Starting soon
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site Recruiting

Other trials for the same condition

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer Active, not recruiting
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Recruiting
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer Active, not recruiting
AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer. Recruiting
A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07049133 on ClinicalTrials.gov ↗ ← All trials in Italy