Clinical trial · Observational
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
NCT06240195CI-TRIAL-00113793BIO-PROSArecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan
- description
- The availability of at least one tumor tissue sample to be transferred to the coordinating center will be essential for enrollment in the study. For patients for whom a new sampling is scheduled biopsy of the tumor (primary or metastasis) as per clinical practice, the feasibility of the development will be assessed tumor organoids and the execution of single-cell sequencing on tumor tissue. In these cases, the order of priority in dividing the sampled tissue will be: sufficient quota to carry out the histological examination that will have to be carried out naturally confirm the diagnosis of triple-negative breast cancer. Quota to be prepared as a fresh preparation for the two experiments of feasibility indicated above; quota to be considered as a second sample, to be analyzed at the end of the study.
- interventionNames
- Other: data collection
Primary outcomes (1)
- measure
- Biomolecular investigations conducted on multiple platforms
- timeFrame
- 30 months
- description
- Identify the predictive factors of the efficacy of sacituzumab govitecan in terms of PFS through biomolecular investigations conducted on multiple platforms, using tumor tissue (where possible both primary and metastatic) and peripheral blood, circulating plasma collected at two separate time points (T0 and T1) of mTNBC patients treated in the real-world setting.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.