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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 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.

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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.

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

FieldValue
Enrollment Target 16 participants
Start Date 2015-05
Est. Completion 2027-07
Phase Phase 2

Sponsor

Wake Forest University Health Sciences

1,140 total trials

What the Registry Record Tells You About NCT02422641

The ClinicalTrials.gov registry entry for NCT02422641 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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