Clinical Trial: NCT03328884
Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cancer Patients
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | MedSIR |
| Information Provided By: | MedSIR |
| Last Update Posted: | 2025-04-23 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Irinotecan (CPT-11) liposome
Other Study ID Numbers
- MedOPP107
- 2016-002689-30
- 2016
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | MedSIR |
| Information Provided By: | MedSIR |
| Last Update Posted: | 2025-04-23 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Irinotecan (CPT-11) liposome
Other Study ID Numbers
- MedOPP107
- 2016-002689-30
- 2016