Metastatic Breast CancerTox-DXdNCT07049133
Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer
An observational study of Metastatic Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- T-DXd toxicity marker identification
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
Who cannot join
- Operable, non-metastatic breast cancer
- Unwillingness to provide additional blood draws
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncolgy
Milan, 20141
Elisabetta Munzone, MD
About this study
Official title: Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
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
Read the 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
- Being tested
- T-DXd toxicity marker identification
- Keywords
- Metastatic Breast Cancer, Trastuzumab-Deruxtecan, ILD/pulmonitis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-DXd toxicity marker identificationOther
to find potential predictive markers associated with T-DXd-related toxicities
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: T-DXd toxicity marker identification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of mean levels of cytokine and T-DXd toxicity
cytokine quantification in blood sample collected at baseline and before cycle 3 day 1
Measured: 2 years
Secondary outcomes (2)
Incidence of T-DXd Treatment Adverse Events
Adverse event (AE) collection with particular focus on ILD/pneumonitis and any other Grade 3 (G3) AE
Measured: 2 years
T-DXd activity evaluation
collection of tumor assessment data during T-DXd therapy
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start31 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabetta Munzone, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049133
- Sponsor's protocol ID
- UID 4972
- Other IDs
- L2-335
- Acronym
- Tox-DXd
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT07049133
- Acronym / sponsor ID
- Tox-DXd / UID 4972
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Trastuzumab-Deruxtecan, ILD/pulmonitis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2-positive or HER2- low/ultralow metastatic patient | – | Other: T-DXd toxicity marker identificationCandidate to receive T-DXd as per standard practice for HER2-positive or HER2- low/ultralow advanced breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Operable, non-metastatic breast cancer
- Unwillingness to provide additional blood draws
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-DXd toxicity marker identificationto find potential predictive markers associated with T-DXd-related toxicities | Other | HER2-positive or HER2- low/ultralow metastatic patient |
Primary outcome
Comparison of mean levels of cytokine and T-DXd toxicity
Time frame: 2 years
cytokine quantification in blood sample collected at baseline and before cycle 3 day 1
2 secondary outcomes
Incidence of T-DXd Treatment Adverse Events
Time frame: 2 years
T-DXd activity evaluation
Time frame: 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elisabetta Munzone, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabetta Munzone, MD (+39 0257489405, elisabetta.munzone@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of mean levels of cytokine and T-DXd toxicity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.