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

Breast Cancer Clinical Trial

— BIO-PROSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06240195
• Other study ID #: RS1814/22
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: June 17, 2025

Study information

• Verified date: March 2024
• Source: Regina Elena Cancer Institute
• Contact: Patrizia Vici, Doctor
• Phone: 06-5266.5584
• Email: patrizia.vici[@]ifo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Identification and inclusion in the study of patients affected by metastatic triple-negative breast cancer mTNBC, treated with sacituzumab govitecan SG as indicated at the participating centers. Histological and biomolecular characteristics will be evaluated both on the tumor at diagnosis and on tissue resulting from biopsy of the metastatic site, where available. Otherwise, the analyzes will come anyway carried out on the most recent and available tumor tissue, whether deriving from primary tumor or site metastatic. The search for biomarkers predictive of efficacy/tolerability will be carried out on tumor tissue (where possible both primary and metastatic) and on circulating plasma collected at two separate time points (T0 and T1). Biomolecular characterization on the biological material of the enrolled patients (tumor tissue and plasma) will be carried out at the end of the study. The feasibility of organoid development and single-cell sequencing will be evaluated on a small subgroup of patients, among those enrolled at the coordinating center, considering the need for tumor tissue prepared fresh for both methods.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 17, 2025
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (12)

Lead Sponsor

Collaborator

Regina Elena Cancer Institute

Azienda Policlinico Umberto I, Campus Bio-Medico University, Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Hospital San Pietro Fatebenefratelli, Ospedale "Gaetano Bernabeo" , Ortona, Ospedale "SS Annunziata", Chieti, Ospedale di Belcolle - Viterbo, Ospedale Sandro Pertini, Roma, presidio Ospedaliero santo spirito in Sassia, Roma, San Giovanni Addolorata Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 months
Secondary	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.	30 months
Secondary	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.	30 months
Secondary	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.	30 months