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Anti-metabolites

High-Dose Methotrexate for Breast Cancer

Phase 2

Recruiting

Led By Roy Strowd, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Group (ECOG) Performance Scale 0-1

Histologically or cytologically confirmed invasive breast cancer of the following subtype: TRIPLE NEGATIVE, HER2-POSITIVE, HORMONE REFRACTORY

Must not have

Partial brain radiotherapy within the last two weeks

Active diabetes insipidus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the use of high-dose methotrexate to treat leptomeningeal disease (LMD) in patients with metastatic breast cancer. LMD is a cancer that has spread to the thin layer of tissue that covers the brain and spinal cord. There is no cure for LMD, and it is a difficult disease to treat because it is hard to reach with traditional cancer treatments. HD-MTX is a chemotherapy drug that has been shown to be effective against breast cancer, and it is hoped that it will be effective against LMD as well. This study is being done to see if HD-MTX is

Who is the study for?

This trial is for adults over 18 with invasive breast cancer that's triple negative, HER2-positive, or hormone refractory. They must have leptomeningeal metastasis confirmed by tests and be in good physical condition (ECOG 0-1). People can't join if they've had certain treatments recently, are pregnant/breastfeeding, have severe heart failure or fluid collections like ascites, adverse reactions to methotrexate before, uncontrolled diseases, or are on conflicting medications.

What is being tested?

The study is testing high-dose Methotrexate (HD-MTX) given intravenously to see if it helps patients with breast cancer who also have leptomeningeal metastasis. It's a phase II trial aiming to provide prospective data since current use of HD-MTX lacks strong evidence but is suggested by retrospective studies and included in NCCN Guidelines due to limited treatment options.

What are the potential side effects?

High-dose Methotrexate may cause side effects such as mouth sores (mucositis), delayed drug clearance leading to increased toxicity especially in patients with significant fluid collections like ascites. Other potential side effects include blood disorders, liver toxicity, kidney problems and lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My breast cancer is triple negative, HER2-positive, or hormone refractory.

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My cancer has spread to the lining of my brain or spinal cord.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had partial brain radiotherapy in the last two weeks.

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I have active diabetes insipidus.

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I currently have mouth sores.

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I have not had chemotherapy or precise radiotherapy in the last 2 weeks.

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My heart condition severely limits my physical activity.

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I am currently undergoing or planning to start treatment for breast cancer.

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I have not had extensive brain radiotherapy in the past 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (at 12 weeks)

Secondary study objectives

Number of Dose Reductions

Number of Treatment Delays

One year survival

+2 more

Other study objectives

Percentage of Cytologic Sterilization

Treatment Cost

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: High-dose Methotrexate (8 gm/m2; HD-MTX)Experimental Treatment1 Intervention

Enrolled patients will undergo treatment with HD-MTX (8 g/m2) as per current standard practice on an every 2 week schedule until disease progression or death from any cause. Treatment will be performed according to standard clinical practice. Surveillance imaging with or without cytologic evaluation will be performed as per standard clinical practice after every 2 cycles (\~28 days). Treatment will continue until there is unequivocal evidence of clinical or radiographic CNS or systemic disease progression, death from any cause, or intolerance.

0 / 10Eligibility criteria met