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New treatment option for Metastatic Breast Cancer
Official title Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
ClinicalTrials.gov ID: NCT02422641
What this study is testing
What is High-dose Methotrexate (8 gm/m2; HD-MTX)?
High-dose Methotrexate (8 gm/m2; HD-MTX) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults (male and female) age \>18
- Eastern Cooperative Group (ECOG) Performance Scale 0-1 (see Appendix I)
- Histologically or cytologically confirmed invasive breast cancer of the following subtype:
- TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease). Triple-negative patients will be defined per ASCO-CAP Guidelines.
- HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP Guidelines.
You likely can't join if
- Prior allergy or adverse reaction to methotrexate
- New York Heart Association Heart Failure Class \>3
- Active diabetes insipidus
- Active mucositis
- Chemotherapy or stereotactic radiotherapy within the last 2 weeks
- Partial brain radiotherapy (i.e. \<40% of total brain volume) within the last 2 weeks
See the full eligibility criteria
- Adults (male and female) age \>18
- Eastern Cooperative Group (ECOG) Performance Scale 0-1 (see Appendix I)
- Histologically or cytologically confirmed invasive breast cancer of the following subtype:
- TRIPLE NEGATIVE (ER-negative, PR-negative, and HER2-negative disease). Triple-negative patients will be defined per ASCO-CAP Guidelines.
- HER2-POSITIVE: HER2-positive patients will be defined per ASCO-CAP Guidelines.
- HORMONE REFRACTORY: Patients with ER/PR-positive disease according to ASCO-CAP guidelines above may be considered if they have disease progression after two lines of hormonal therapy (administered in the adjuvant or...
- Cytologic or unequivocal radiographic confirmation of leptomeningeal metastasis by dural puncture and/or neuroimaging with or without known brain 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...
- Prior allergy or adverse reaction to methotrexate
- New York Heart Association Heart Failure Class \>3
- Active diabetes insipidus
- Active mucositis
- Chemotherapy or stereotactic radiotherapy within the last 2 weeks
- Partial brain radiotherapy (i.e. \<40% of total brain volume) within the last 2 weeks
- Whole brain radiotherapy within the last 6 months or partial brain radiotherapy exceeding \>40% of total brain volume within the last 6 months
- Prior treatment with any methotrexate containing systemic regimen within 1 year (excluding intrathecal methotrexate)
- Concurrent or planned systemic chemotherapy, radiotherapy, new hormonal or anti- HER2 directed therapy directed at management of breast cancer (existing anti-HER2 therapy can be continued as recently recommended in the...
- Uncontrolled or progressive systemic disease or other concurrent condition which in the Investigator's opinion makes HD-MTX an undesirable treatment option for the patient or would jeopardize compliance
- Contraindication to MRI
- Use of salicylates, non-steroidal anti-inflammatory drugs, or sulfonamide medications within one week of start of methotrexate
- Pregnant women or women who are breastfeeding.
- Patients with significant visceral fluid collections including ascites, pericardial effusions, pleural effusions or others may experience delayed clearance of methotrexate because of third space accumulation which could...
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; St Louis, Missouri, United States; Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.