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Clinical Trials in Italy / NCT06240195
Recruiting 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

NCT06240195 · tracked via the Priya Life Science Italy tracker
Sponsor
Regina Elena Cancer Institute
Phase
Observational
Started
2023-01-17
Last updated
2026-06-05

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

data collection

data 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

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Biomolecular investigations conducted on multiple platforms — 30 months
    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.

Trial sites (1)

FacilityCityRegionStatus
"Regina Elena" National Cancer Institute Rome Rome Recruiting

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Other trials for the same condition

TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study A) Active, not recruiting
The OPBC-07/microNAC Study Active, not recruiting
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Recruiting
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study Active, not recruiting
Music Therapy in Patients With Breast Cancer (IMPACT) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06240195 on ClinicalTrials.gov ↗ ← All trials in Italy