OncoMatch/Clinical Trials/NCT02422641
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
Is NCT02422641 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies High-dose Methotrexate (8 gm/m2; HD-MTX) for metastatic breast cancer.
Treatment: High-dose Methotrexate (8 gm/m2; HD-MTX) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (ER-negative)
TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease)
Required: PR (PGR) negative (PR-negative)
TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease)
Required: HER2 (ERBB2) negative (HER2-negative)
TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease)
Required: HER2 (ERBB2) overexpression (HER2-positive)
HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP Guidelines.
Allowed: ESR1 positive
HORMONE REFRACTORY: Patients with ER/PR-positive disease... may be considered if they have disease progression after two lines of hormonal therapy... or are deemed clinically hormone-resistant...
Allowed: PR (PGR) positive
HORMONE REFRACTORY: Patients with ER/PR-positive disease... may be considered if they have disease progression after two lines of hormonal therapy... or are deemed clinically hormone-resistant...
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hormonal therapy — adjuvant or metastatic
disease progression after two lines of hormonal therapy (administered in the adjuvant or metastatic setting), or are deemed clinically hormone-resistant
Cannot have received: methotrexate containing systemic regimen (methotrexate)
Exception: excluding intrathecal methotrexate
Prior treatment with any methotrexate containing systemic regimen within 1 year (excluding intrathecal methotrexate)
Cannot have received: chemotherapy
Chemotherapy... within the last 2 weeks
Cannot have received: stereotactic radiotherapy
stereotactic radiotherapy within the last 2 weeks
Cannot have received: whole brain radiotherapy
Whole brain radiotherapy within the last 6 months
Cannot have received: partial brain radiotherapy
Exception: partial brain radiotherapy <40% of total brain volume within the last 2 weeks; partial brain radiotherapy >40% of total brain volume within the last 6 months
Partial brain radiotherapy (i.e. <40% of total brain volume) within the last 2 weeks; partial brain radiotherapy exceeding >40% of total brain volume within the last 6 months
Lab requirements
Blood counts
White blood cell counts >3000 cells/mcL; Absolute neutrophil count >1500 cells/mcL; Platelet count >100,000 cells/mcL; Hematocrit >30%
Kidney function
Estimated creatinine clearance >70 cc/min (Cockcroft-Gault formula)
Liver function
Serum bilirubin <1.5 x the ULN or <5x the ULN if secondary to liver metastasis; ALT or AST <2.5x the ULN or <5x the ULN if secondary to liver metastasis; Alkaline phosphatase <2.5x the ULN or <5x the ULN if secondary to liver metastasis
Adequate organ function as follows: Estimated creatinine clearance >70 cc/min (calculated by Cockcroft-Gault formula) White blood cell counts >3000 cells/mcL Absolute neutrophil count >1500 cells/mcL Platelet count >100,000 cells/mcL Hematocrit >30% Serum bilirubin <1.5 x the ULN or <5x the ULN if secondary to liver metastasis Alanine aminotransferase or aspartate aminotransferase <2.5x the ULN or <5x the ULN if secondary to liver metastasis Alkaline phosphatase <2.5x the ULN or <5x the ULN if secondary to liver metastasis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sidney Kimmel Comprehensive Cancer Center · Baltimore, Maryland
- Siteman Cancer Center- Washington University School of Medicine in St. Louis · St Louis, Missouri
- Comprehensive Cancer Center at Wake Forest University (CCCWFU) · Winston-Salem, North Carolina
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