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Trial 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
NCT ID:
NCT06240195
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
data collection
Description:
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
Arm group label:
patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan
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.
Criteria for eligibility:
Study pop:
Patients with metastatic triple-negative breast cancer treated with socituzumab govitecan
as indicated, with at least one sample of tumor tissue available.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Patrizia Vici, Doctor
Phone:
06-5266.5584
Phone ext:
+39
Email:
patrizia.vici@ifo.it
Start date:
January 17, 2023
Completion date:
June 17, 2025
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Collaborator:
Agency:
Ospedale Sandro Pertini, Roma
Agency class:
Other
Collaborator:
Agency:
Catholic University of the Sacred Heart
Agency class:
Other
Collaborator:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Collaborator:
Agency:
Campus Bio-Medico University
Agency class:
Other
Collaborator:
Agency:
Azienda Policlinico Umberto I
Agency class:
Other
Collaborator:
Agency:
San Giovanni Addolorata Hospital
Agency class:
Other
Collaborator:
Agency:
Ospedale "SS Annunziata", Chieti
Agency class:
Other
Collaborator:
Agency:
Ospedale "Gaetano Bernabeo" , Ortona
Agency class:
Other
Collaborator:
Agency:
Hospital San Pietro Fatebenefratelli
Agency class:
Other
Collaborator:
Agency:
presidio Ospedaliero santo spirito in Sassia, Roma
Agency class:
Other
Collaborator:
Agency:
Ospedale di Belcolle - Viterbo
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06240195
