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

European Institute of Oncology

Status: Enrolling

Conditions: Metastatic Breast Cancer

Treatments: Other: T-DXd toxicity marker identification

Study type: Observational

Funder types: Other

Identifiers

NCT07049133

L2-335

UID 4972

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

84 participants in 1 patient group

HER2-positive or HER2- low/ultralow metastatic patient

Description:

Candidate to receive T-DXd as per standard practice for HER2-positive or HER2- low/ultralow advanced breast cancer.

Treatment:

Other: T-DXd toxicity marker identification