Biomarkers of Efficacy and Tolerability of Sacituzumab-Govitecan in Treating Metastatic Triple-negative Breast Cancer Prospective Multicenter Real-world Study
Led by Regina Elena Cancer Institute
Updated on 2026-06-05
60
Participants Needed
1
Research Sites
125 weeks
Total Duration
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Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
O
Ospedale Sandro Pertini, Roma
Collaborating Sponsor
AI-Summary
What This Trial Is About
Researchers are studying the use of sacituzumab govitecan in patients with metastatic triple-negative breast cancer mTNBC. This observational, prospective, multicenter study aims to collect real-world data on the drugs effectiveness and investigate biomarkers that may predict how well patients tolerate and respond to this treatment.
The study focuses on analyzing tumor tissue and plasma samples to better understand treatment outcomes. Participants will be patients diagnosed with mTNBC who are receiving sacituzumab govitecan as part of their clinical care. Tumor tissue samples, either from the primary tumor or metastatic sites, will be collected and analyzed at diagnosis and during treatment. In some cases, fresh tissue will be used to explore organoid development and single-cell sequencing to further evaluate the disease on a cellular level. During the study, researchers will gather biomolecular data from tumor and plasma samples at two time points. They will monitor progression-free survival and the treatments tolerability over 30 months. Participants will provide consent for tissue sample transfer and undergo assessments as per the study protocol. The findings will help understand treatment effects and identify predictive markers, with all data collected being part of the long-term evalua
📌 Biomarkers Of Efficacy And Tolerability Of Sacituzumab-Govitecan In Treating Metastatic Triple-Negative Breast Cancer Prospective Multicenter Real-World Study (Roma)
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