Studies how sacituzumab govitecan works in adults with metastatic triple-negative breast cancer
Collects real-world data and biomarkers in adults with metastatic triple-negative breast cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Regina Elena National Cancer InstituteRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regina Elena Cancer Institute
- Trial code
- NCT06240195
- Record updated
- 5 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Patients with a history of other malignancies; Contraindications to the use of sacituzumab govitecan SG; Untreated and/or clinically unstable (symptomatic) brain metastases.