A Randomized Open-Label, Multi-Center Pivotal Study of ANG1005 Compared with Physician’s Best Choice in HER2-Negative Breast Cancer Patients with Newly Diagnosed Leptomeningeal Carcinomatosis and Previously Treated Brain Metastases (ANGLeD)
Clinical Trial Information
Trial Contact: Manchola-Orozco, Carolina; Walton, Sherri
IRB No: 18.131.09
Protocol Abbrev: ANG1005-CLN-07
Principal Investigator: Nicholas G. Avgeropoulos, MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: ANG1005
Treatment: paclitaxel trevatide, capecitabine, eribulin, high-dose IV methotrexate
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT03613181
Primary Objective: To determine the overall survival (OS) for patients randomized to ANG1005 vs. Physician’s Best Choice
Secondary Objective: To further evaluate the efficacy of ANG1005 vs. Physician’s Best Choice in terms
• CNS (leptomeningeal and parenchymal) progression-free survival (PFS)
• CNS (leptomeningeal and parenchymal) clinical benefit rate (stable disease or better) at 3, 6 and 12 months
• 6-Month and 12-month overall survival rates
• LC response rate (RR) and duration of response
• OS for triple negative (HER2-/ER-/PR-) patients
1. Histologically or cytologically documented HER2-negative breast cancer
2. At least 2 months of expected OS.
3. Newly diagnosed LC, with radiological and/or cytological confirmation.
4. Documented history of parenchymal BM that has been previously treated with at least one course of radiation therapy.
5. Neurologically stable, receiving stable doses of corticosteroids, RT and anticonvulsants (no enzyme-induced antiepileptic drugs [EIAEDs]) for >1 week prior to first dose.
6. Eastern Cooperative Oncology Group (ECOG) performance status grade <2.
7. Adequate laboratory test results for organ systems prior to first dose