drugset
drugset / Trial / NCT05520723

Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED

NCT05520723 ↗

Phase 2 Completed 50 enrolled MedSIR Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

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) or Luminal breast cancer, 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 or Luminal breast cancer.

Timeline

Start
2023-02-06
Primary completion
2023-10-18
Completion
2025-11-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous
Background Loperamide Small molecule 2 mg Oral
Background Loperamide Small molecule 4 mg Oral
Background filgrastim Protein / enzyme biologic 30 iu Subcutaneous

Indications

hormone receptor-positive breast cancer triple-negative breast carcinoma