Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: T-DXd toxicity marker identification.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification Of Toxicity Markers to Trastuzumab-Deruxtecan (T-DXd) In Patients With Advanced Breast Cancer. Tox-DXd: a Prospective, Observational Study
Overview
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.
Interventions
- Other T-DXd toxicity marker identification
to find potential predictive markers associated with T-DXd-related toxicities
Primary outcome measures
- Comparison of mean levels of cytokine and T-DXd toxicity [Time frame: 2 years]
Secondary outcome measures (2)
- Incidence of T-DXd Treatment Adverse Events [Time frame: 2 years]
- T-DXd activity evaluation [Time frame: 8 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- European Institute of Oncolgy — Milan
Identifiers
NCT: NCT07049133 · UID 4972 · L2-335