RecruitingNCT06240195

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

Sponsor

Regina Elena Cancer Institute

Enrollment

60 participants

Start Date

Jan 17, 2023

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria3

Patients with a history of other malignancies;
Contraindications to the use of sacituzumab govitecan SG;
Untreated and/or clinically unstable (symptomatic) brain metastases.

Interventions

OTHERdata collection

Collection of data relating to the effectiveness of sacituzumab govitecan and evaluation in a real-world context and planned research of predictive biomarkers of efficacy/tolerability