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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorRegina Elena Cancer Institute

About this trial

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 criteria

Qualifiers

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);

Disqualifiers

Patients with a history of other malignancies;

Contraindications to the use of sacituzumab govitecan SG;

Untreated and/or clinically unstable (symptomatic) brain metastases.

Trial design

Treatments tested in this trial

  • data collection

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

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