drugset / Trial / NCT05552001

Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer

NCT05552001

Phase 3 Recruiting 96 enrolled UNICANCER Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

Summary

ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or within 6 months after the end of curative treatments in order to: 1. evaluate the treatment efficacy in less pretreated patients. 2. identify biomarkers that could predict response or resistance to the drug.

Timeline

Start
2023-10-05
Primary completion
2026-05-01
Completion
2028-05-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Other