Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in the Treatment of Patients With Triple-negative Breast Cancer in the Metastatic Phase: Prospective Multicenter Real-world Study
Recruiting · NCT06240195 · Observational (researchers observe without assigning treatment) · Lead sponsor: Regina Elena Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
data collection
What this trial is about
Observational, prospective, multicenter study. Collection of data relating to the effectiveness of sacituzumab govitecan SG, in a real-world context and planned research of predictive biomarkers of efficacy/tolerability carried out on multiple platforms at the center coordinator.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age ≥ 18 years;
- Histological diagnosis of TNBC;
- Locally advanced unresectable or metastatic disease;
- Indication for treatment with SG in monotherapy according to clinical practice (patients pre-treated with at least two lines of systemic therapy, of which at least one in an advanced stage);
- Availability of at least one tumor tissue sample (from primary tumor or metastasis) to be sent to the coordinating center (IRE);
- Written informed consent;
- Availability to comply with the procedures established by the protocol, according to the methods and times described.
Exclusion criteria
- Patients with a history of other malignancies;
- Contraindications to the use of sacituzumab govitecan SG;
- Untreated and/or clinically unstable (symptomatic) brain metastases.
Where it is running
1 location listed.
- "Regina Elena" National Cancer Institute - Rome, Rome, Italy