Phase 2
N=9
Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
Metastatic Breast Cancer · Brain Metastases
Bottom Line
View on ClinicalTrials.gov: NCT02581839 ↗Enrolled (actual)
9
Serious AEs
33.3%
Results posted
Mar 2020
Primary outcome: Primary: Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS) — 88.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Eribulin Mesylate (Drug); MRI (Device); Pre-Medication: Zofran (Drug); Pre-Medication: Decadron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS) |
88.9 | — |
| SECONDARY Objective Response Rate (RR) |
11.1 | — |
| SECONDARY Median Duration of CNS Response |
22.6 | — |
| SECONDARY Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events |
3 | — |
| SECONDARY Number of Patients With CBR |
5 | — |
| SECONDARY Systemic Disease Response Rate |
— | — |
| SECONDARY Median Overall Survival (OS) |
15.7 | — |
Summary
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.
Eligibility Criteria
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 450ms.
- Patients with grade 3/4 peripheral neuropathy.
- Patients with pacemaker or an ICD devices.
- Previous treatment with eribulin mesylate.
Data sourced from ClinicalTrials.gov (NCT02581839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.