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

NCT07049133 | Recruiting

• 2 other identifiers: UID 4972L2-335
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Trastuzumab-Deruxtecan; ILD/pulmonitis

Outcome Measures

Primary Outcomes (1)

• Comparison of mean levels of cytokine and T-DXd toxicity

  cytokine quantification in blood sample collected at baseline and before cycle 3 day 1

  2 years

Secondary Outcomes (2)

• Incidence of T-DXd Treatment Adverse Events

  2 years

• T-DXd activity evaluation

  8 months

Study Arms (1)

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.

Other: T-DXd toxicity marker identification

Interventions

T-DXd toxicity marker identification OTHER

to find potential predictive markers associated with T-DXd-related toxicities

HER2-positive or HER2- low/ultralow metastatic patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

male or female advanced breast cancer patient, either HER2-positive or HER2-low/ultralow, candidate to receive T-DXd as per standard practice

You may qualify if:

• 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.

You may not qualify if:

• Operable, non-metastatic breast cancer
• Unwillingness to provide additional blood draws

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncolgy

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elisabetta Munzone, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabetta Munzone, MD

CONTACT

+39 0257489405; elisabetta.munzone@ieo.it

Davide Merli, PHD

CONTACT

+39 0294372213; davide.merli@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

IT (1)