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.
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);
Patients with a history of other malignancies;
Contraindications to the use of sacituzumab govitecan SG;
Untreated and/or clinically unstable (symptomatic) brain metastases.
Patients with metastatic triple-negative breast cancer treated with socituzumab govitecan as indicated, with at least one sample of tumor tissue available.
Other
Prospective
data collection
Other interventionCollection 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
Biomolecular investigations conducted on multiple platforms
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.
PFS in patients.
Assess any differences in terms of PFS in patients treated in second line compared to patient treated in lines subsequent to the second. Evaluate the dynamics of quantitative variation over time of any circulating microRNAs predictive of efficacy and tolerability. Evaluate the differences in any predictive biomarkers of efficacy/tolerability, tissue and/or circulating, in patients treated in second line vs patients treated in subsequent lines. Assess any differences in PFS in relation to: previous treatment(s) in the early setting and metastatic, disease sites, dose reductions/treatment discontinuation.
Tolerability of the treatment
Evaluate the tolerability of the treatment in terms of adverse events, defined according to Common Terminology Criteria for Adverse Events (CTCAE, v. 5) and identify factors predictive of toxicity. Evaluate objective response rate (ORR) and overall survival (OS). Assess the variation in any biomarkers of efficacy in primary tumor tissue vs. tissue from metastatic localization (in cases where both samples are available). Select a small subgroup of patients from whose tumor tissue to develop organoids will be treated with SG, and on which potential will be quantified longitudinally over time biomarkers of response to treatment.
Development of organoids
Select a small subgroup of patients from the tumor tissue for single cell testing RNA sequencing to compare with data from bulk RNA sequencing to study the microenvironment tumoral.
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Regina Elena Cancer Institute
Lead sponsor
Ospedale Sandro Pertini, Roma
Collaborator
Catholic University of the Sacred Heart
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Campus Bio-Medico University
Collaborator
Azienda Policlinico Umberto I
Collaborator
San Giovanni Addolorata Hospital
Collaborator
Ospedale "SS Annunziata", Chieti
Collaborator
Ospedale "Gaetano Bernabeo" , Ortona
Collaborator
Hospital San Pietro Fatebenefratelli
Collaborator
presidio Ospedaliero santo spirito in Sassia, Roma
Collaborator
Ospedale di Belcolle - Viterbo
Collaborator
