NCT02422641

Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

Traditional Incision and Drainage of Cutaneous Abscess Vs. Minimally Invasive Incision and Drainage With Vessel Loop: A Randomized Controlled Trail

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 metastatic breast cancer treated with HD-MTX. * To describe the tolerability of HD-MTX in patients with LMD from metastatic breast cancer. * To describe the cost of HD-MTX treatment in patients with LMD from metastatic breast cancer. * To investigate cytologic sterilization following HD-MTX in patients with LMD from metastatic breast cancer.

Conditions

• Metastatic Breast Cancer
• Leptomeningeal Disease

Interventions

Type	Name	Description
DRUG	High-dose Methotrexate (8 gm/m2; HD-MTX)	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.

Timeline

• Start date: 2015-05-01
• Primary completion: 2026-05-01
• Completion: 2027-07-01
• First posted: 2015-04-21
• Last updated: 2026-03-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study