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NCT02422641 · ClinicalTrials.gov registry record · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
A Phase 2 study of Metastatic Breast Cancer and Leptomeningeal Disease, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 3
- Study locations
NCT02422641: Recruiting Phase 2 study of Metastatic Breast Cancer and Leptomeningeal Disease, sponsored by Wake Forest University Health Sciences.
NCT02422641 is a Phase 2 study of Metastatic Breast Cancer and Leptomeningeal Disease that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 16 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02422641, a Phase 2 study of Metastatic Breast Cancer and Leptomeningeal Disease, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
The primary endpoint is survival at 12 weeks from first date of treatment. For the primary analysis, this will be dichotomized according to whether the patient achieves an OS greater than 12 weeks (i.e. survival rate). This cutoff has been selected based on reported OS data in historical controls.
Conditions Studied
Interventions
- DRUG High-dose Methotrexate (8 gm/m2; HD-MTX)
Study Locations (3)
Maryland
- Sidney Kimmel Comprehensive Cancer Center - Baltimore
Missouri
- Siteman Cancer Center- Washington University School of Medicine in St. Louis - St Louis
North Carolina
- Comprehensive Cancer Center at Wake Forest University (CCCWFU) - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-05 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT02422641 shows while recruiting
NCT02422641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which High-dose Methotrexate (8 gm/m2; HD-MTX) is the first listed.
NCT02422641 reports a single indexed study location in Maryland, Missouri, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02422641 about?
NCT02422641 is a clinical study titled "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.
What is the current status of trial NCT02422641?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2015-05. Estimated completion is 2027-07.
What conditions does trial NCT02422641 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Leptomeningeal Disease.
What interventions are being tested in trial NCT02422641?
The interventions under investigation include: High-dose Methotrexate (8 gm/m2; HD-MTX) (DRUG).
Who is sponsoring clinical trial NCT02422641?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02422641 being conducted?
This trial has 3 study locations across Maryland, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02422641's enrollment target sits among peer trials
16 126th of 139 higher than 13 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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