Breast Cancer
Conditions
Brief 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.
Detailed 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.
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
Sponsors
Regina Elena Cancer Institute
Ospedale Sandro Pertini, Roma
Catholic University of the Sacred Heart
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Campus Bio-Medico University
Azienda Policlinico Umberto I
San Giovanni Addolorata Hospital
Ospedale "SS Annunziata", Chieti
Ospedale "Gaetano Bernabeo" , Ortona
Hospital San Pietro Fatebenefratelli
presidio Ospedaliero santo spirito in Sassia, Roma
Ospedale di Belcolle - Viterbo
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS in patients. | 30 months | 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 | 30 months | 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 | 30 months | 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. |
Countries
Italy
Contacts
CONTACTPatrizia Vici, Doctor
CONTACTEriseld Krasniqi, Doctor
PRINCIPAL_INVESTIGATORPatrizia Vici, Doctor
IRCCS "Regina Elena" National Cancer Institute
Outcome results
None listed