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

NCT ID: NCT07049133

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-12-31

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

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

T-DXd toxicity marker identification

Intervention Type: OTHER

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

Interventions

T-DXd toxicity marker identification

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabetta Munzone, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncolgy

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elisabetta Munzone, MD

Role: CONTACT

elisabetta.munzone@ieo.it

+39 0257489405

Davide Merli, PHD

Role: CONTACT

davide.merli@ieo.it

+39 0294372213

Facility Contacts

Elisabetta Munzone, MD

Role: primary

Other Identifiers

L2-335

Identifier Type: OTHER

Identifier Source: secondary_id

UID 4972

Identifier Type: -

Identifier Source: org_study_id