Preventive stRategy for IMMU132-relatED AEs in TNBC
Status:
Not yet recruiting
Trial end date:
2025-12-14
Target enrollment:
Participant gender:
Summary
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.