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 (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT02422641 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior methotrexate containing systemic regimen, chemotherapy, stereotactic radiotherapy disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages