NCT06240195Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 12 Jan 2024
- Start date
- 17 Jan 2023
- Primary completion date
- 17 Jan 2025
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06240195
What you commit to
- Study type: Observational
- Planned participants: 60
- From 17 Jan 2023 to the primary completion date, 17 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with a history of other malignancies;
Other
- Contraindications to the use of sacituzumab govitecan SG;
- Untreated and/or clinically unstable (symptomatic) brain metastases.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regina Elena National Cancer Institute Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.