Clinical trial NCT06240195: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Ospedale Sandro Pertini, Roma
name: Catholic University of the Sacred Heart
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Campus Bio-Medico University
name: Azienda Policlinico Umberto I
name: San Giovanni Addolorata Hospital
name: Ospedale "SS Annunziata", Chieti
name: Ospedale "Gaetano Bernabeo" , Ortona
name: Hospital San Pietro Fatebenefratelli
name: presidio Ospedaliero santo spirito in Sassia, Roma
name: Ospedale di Belcolle - Viterbo
First posted: 2024-02-02
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic triple-negative breast cancer treated with socituzumab govitecan as indicated, with at least one sample of tumor tissue available.

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.

Eligibility 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.

Primary outcomes:
measure: Biomolecular investigations conducted on multiple platforms
timeFrame: 30 months
Secondary outcomes:
measure: PFS in patients.
timeFrame: 30 months
measure: Tolerability of the treatment
timeFrame: 30 months
measure: Development of organoids
timeFrame: 30 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
affiliation: IRCCS "Regina Elena" National Cancer Institute
name: Patrizia Vici, Doctor
role: PRINCIPAL_INVESTIGATOR
References: