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

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.

Trial Details

NCT ID
NCT02422641
Phase
PHASE2
Sponsor
Wake Forest University Health Sciences
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • High-dose Methotrexate (8 gm/m2; HD-MTX)
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • St Louis, Missouri, United States|38.62727,-90.19789
  • Winston-Salem, North Carolina, United States|36.09986,-80.24422

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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