drugset / Trial / NCT03328884

Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cancer Patients

NCT03328884 ↗

Phase 2 Completed 55 enrolled MedSIR
NaSingle-groupOpen-labelTreatment

Summary

Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI in patients with HER2-negative breast cancer, who have documented Central Nervous System (CNS) progression following Whole Brain Radio Therapy (WBRT), Stereotactic Radiosurgery (SRS) and/or surgery, as determined by the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.

Timeline

Start
2017-05-02
Primary completion
2018-08-31
Completion
2025-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 50 mg/m2 —