This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g/m2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.
Adults (male and female) age >18
Eastern Cooperative Group (ECOG) Performance Scale 0-1 (see Appendix I)
TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease). Triple-negative patients will be defined per ASCO-CAP Guidelines.
HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP Guidelines.
Prior allergy or adverse reaction to methotrexate
New York Heart Association Heart Failure Class >3
Active diabetes insipidus
Active mucositis
Wake Forest University Health Sciences
Lead sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborator
National Cancer Institute (NCI)
Collaborator