ANG1005 in Leptomeningeal Disease From Breast Cancer
NCT03613181 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-04-24
Summary
This is an open-label Phase 3 study to see if ANG1005 can prolong survival compared to a Physician Best Choice control in HER2-negative breast cancer patients with newly diagnosed leptomeningeal disease and previously treated brain metastases.
Conditions
- Leptomeningeal Carcinomatosis
- Leptomeningeal Metastases
- Brain Metastases
- HER2-negative Breast Cancer
Interventions
- DRUG
-
ANG1005
Investigational drug
- DRUG
-
Physician's Best Choice
Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
Sponsors & Collaborators
-
Angiochem Inc
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-31
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
- FDA Drug
- Yes
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