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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Investigational drug
Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
Overall survival
Time frame: From the date of randomization until death due to any cause, assessed for up to 2 years.
Central nervous system progression-free survival
Time frame: From the date of randomization until central nervous system progression, assessed for up to 2 years.
Central nervous system clinical benefit rate at 3, 6 and 12 months
Time frame: At 3, 6 and 12 months.
6-month and 12-month overall survival rates
Time frame: At 6 and 12 months.
Leptomeningeal carcinomatosis response rate
Time frame: Assessed for up to 2 years from first patient randomised.
Duration of leptomeningeal carcinomatosis response
Time frame: Assessed for up to 2 years from first patient randomised.
Overall survival in triple negative breast cancer patients
Time frame: From the date of randomization until death due to any cause, assessed for up to 2 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.