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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Regina Elena National Cancer Institute
RECRUITING
Rome
Contact Information
Primary
Patrizia Vici, Doctor
patrizia.vici@ifo.it
06-5266.5584
Backup
Eriseld Krasniqi, Doctor
eriseld.krasniqi@ifo.it
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2027-06-17
Participants
Target number of participants: 60
Treatments
patients with metastatic triple-negative breast cancer treated with sacituzumab govitecan
The availability of at least one tumor tissue sample to be transferred to the coordinating center will be essential for enrollment in the study. For patients for whom a new sampling is scheduled biopsy of the tumor (primary or metastasis) as per clinical practice, the feasibility of the development will be assessed tumor organoids and the execution of single-cell sequencing on tumor tissue. In these cases, the order of priority in dividing the sampled tissue will be: sufficient quota to carry out the histological examination that will have to be carried out naturally confirm the diagnosis of triple-negative breast cancer. Quota to be prepared as a fresh preparation for the two experiments of feasibility indicated above; quota to be considered as a second sample, to be analyzed at the end of the study.
Related Therapeutic Areas
Sponsors
Collaborators: San Giovanni Addolorata Hospital, presidio Ospedaliero santo spirito in Sassia, Roma, Catholic University of the Sacred Heart, Ospedale Gaetano Bernabeo , Ortona, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Ospedale Sandro Pertini, Roma, Azienda Policlinico Umberto I, Campus Bio-Medico University, Ospedale SS Annunziata, Chieti, Ospedale di Belcolle - Viterbo, Hospital San Pietro Fatebenefratelli
Leads: Regina Elena Cancer Institute

This content was sourced from clinicaltrials.gov