Wake Forest University Health Sciences
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.
Primary Objective: \- To assess if treatment with systemic intravenous high-dose methotrexate (HD-MTX) will result in an overall survival (OS) exceeding 12 weeks at 80% among patients with triple negative, HER2-positive, and hormone refractory metastatic breast cancer patients with leptomeningeal metastasis (LMD) with and without parenchymal brain involvement. Secondary and Exploratory Objectives * To describe the one-year survival in patients with LMD from metastatic breast cancer treated with HD-MTX. * To describe the overall progression free survival (PFS) in patients with LMD from metas…
Inclusion Criteria * Adults (male and female) age \>18 * Eastern Cooperative Group (ECOG) Performance Scale 0-1 (see Appendix I) * Histologically or cytologically confirmed invasive breast cancer of the following subtype: * 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. * HORMONE REFRACTORY: Patients with ER/PR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after tw…
Enrolled patients will undergo treatment with HD-MTX (8 g/m2) as per current standard practice on an every 2 week schedule until disease progression or death from any cause. Treatment will be performed according to standard clinical practice. Surveillance imaging with or without cytologic evaluation will be performed as per standard clinical practice after every 2 cycles (\~28 days). Treatment will continue until there is unequivocal evidence of clinical or radiographic CNS or systemic disease progression, death from any cause, or intolerance.
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