Clinical trial · Interventional
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
NCT02581839CI-TRIAL-00046295completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Subjects are asked to take part in a clinical research study that tests Eribulin, a new drug. Eribulin is an investigational (experimental) anti-cancer agent that has not been approved by the Food and Drug Administration (FDA) for use in patients with brain metastases. Eribulin is FDA approved for use in patients with metastatic breast cancer but the effect it may or may not have on brain metastases has not been studied.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eribulin Mesylate | Drug | Eribulin | ALIAS |
| MRI | Device | — | UNRESOLVED |
| Pre-Medication: Decadron | Drug | — | UNRESOLVED |
| Pre-Medication: Zofran | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eribulin Mesylate
- description
- The recommended starting dose of eribulin mesylate is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
- interventionNames
- Drug: Eribulin Mesylate
- Device: MRI
- Drug: Pre-Medication: Zofran
- Drug: Pre-Medication: Decadron
Primary outcomes (1)
- measure
- Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
- timeFrame
- At 12 weeks
- description
- The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female with histologically confirmed breast cancer. * Patients must have evidence of metastatic disease (non measurable disease is eligible). * Radiologically confirmed metastatic brain lesion by MRI. * Brain metastases from breast cancer with or without prior WBRT, STS of surgical resection. Progression must be documented in an at least one lesion untreated by SRS or in any site after surgery or WBRT. * Patients must be neurologically stable and with stable dose steroids and anticonvulsants for at least 1 week prior to obtaining the baseline MRI of the brain, and/or at least 1 week prior to beginning study treatment. * No presence of uncontrolled systemic disease or tumor related complication which, in opinion of the investigator, might restrict life expectancy to less than 3 months. * Patients may not be on any cytotoxic chemotherapy or hormonal treatment for breast cancer during protocol treatment. Trastuzumab is allowed in HER2 positive patients). * Able to comprehend and willing to sign an Informed Consent Form (ICF) * Karnofsky performance status ≥ 60 * No brain radiation therapy \> 4 weeks * No chemotherapy for \> 3 weeks before planned start of protocol treatment * Adequate bone marrow, renal, and hepatic function, per local reference laboratory ranges as follows: * Absolute neutrophil count (ANC) ≥ 1,500/mm3 * Platelet count ≥ 100,000/mm3 * Hemoglobin ≥ 9 g/dL * Calculated creatinine clearance (CrCl) ≥ 30mL/min (Cockcroft-Gault method) * Patients with normal, mild or moderate hepatic dysfunction are eligible. * Calcium \<10.1 mg/dL (corrected to serum albumin as follows: Corrected Calcium = (0.8 x (4 - patient albumin)) + serum Ca * Females of child-bearing potential must have a negative pregnancy test at screening and agree to take appropriate precautions to avoid pregnancy (double barrier method of birth control or abstinence) from screening through 3 months after the last dose of treatment * Able to undergo MRI evaluation with and without gadolinium contrast Exclusion Criteria: * Patients with the presence of an active infection, abscess or fistula * Known leptomeningeal disease or CNS midline shifts. * Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease. * Severe conduction abnormality including significant QTc prolongation \>450ms. * Patients with grade 3/4 peripheral neuropathy. * Patients with pacemaker or an ICD devices. * Previous treatment with eribulin mesylate.
References
Publications (0)
Data not yet available
No reference posted for this study.