Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Pat... | NCT07049133

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

NCT07049133

Sponsor

European Institute of Oncology

Status

Recruiting

Last Update Posted

Jan 6, 2026Actual

Enrollment

84Estimated

Phase

Not provided

Conditions

Metastatic Breast Cancer

Interventions

T-DXd toxicity marker identification

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
L2-335	Other Identifier	Comitato Etico Territoriale Lombardia 2

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jun 25, 2025

First Submission Date that Met QC Criteria

Jun 25, 2025

First Posted Date

Jul 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 2, 2026

Last Update Posted Date

Jan 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Incidence of T-DXd Treatment Adverse Events	Adverse event (AE) collection with particular focus on ILD/pneumonitis and any other Grade 3 (G3) AE	2 years
T-DXd activity evaluation	collection of tumor assessment data during T-DXd therapy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elisabetta Munzone, MD	Contact	+39 0257489405		elisabetta.munzone@ieo.it
Davide Merli, PHD	Contact	+39 0294372213		davide.merli@ieo.it

Overall Officials

Name	Affiliation	Role
Elisabetta Munzone, MD	European Institute of Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
European Institute of Oncolgy	Recruiting	Milan		20141	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided