Breast Cancer Clinical Trial
Official title:
Multicenter, Open-label, Single Arm, Phase II Clinical Trial to Improve Sacituzumab Govitecan's Tolerance in Patients With Metastatic Triple-Negative Breast Cancer.
This is a multicenter, open-label, single-arm, multicohort, two-stage optimal Simon's design, phase II clinical trial that is designed to improve the tolerance of sacituzumab govitecan in patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC), refractory to at least one, and no more than two, prior standard of care chemotherapy regimens in this setting that is not amenable to resection with curative intent. The goal of this study is to evaluate the safety of sacituzumab govitecan in combination with loperamide and G-CSF in pretreated patients with unresectable locally advanced or metastatic TNBC.
The hypothesis of this study is that the prophylactic administration of loperamide (for diarrhea) and G-CSF therapies (for neutropenia) would avoid these undesirable effects when patients are treated with sacituzumab govitecan, thus decreasing the rate of dose reduction or discontinuation, and significantly improving patients' quality of life. The main objectives of this study are: Primary objective: - To evaluate the incidence of diarrhea and neutropenia in patients with unresectable locally advanced or metastatic TNBC treated with sacituzumab govitecan in combination with loperamide and G-CSF. Secondary objectives: - To determine the safety and tolerability of the study regimen in this patient population. - To determine the efficacy of the study regimen in this patient population. ;
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