Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

NCT02581839 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE7113
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Metastatic Breast Cancer; Brain Metastases

Keywords

eribulin; central nervous system; CNS; Eribulin Mesylate; Halaven

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)

  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.

  At 12 weeks

Secondary Outcomes (6)

• Objective Response Rate (RR)

  up to 2 years from start of treatment

• Median Duration of CNS Response

  up to 2 years from start of treatment

• Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events

  up to 2 years from start of treatment

• Number of Patients With CBR

  At 12 weeks

• Systemic Disease Response Rate

  up to 2 years from start of treatment

Study Arms (1)

Eribulin Mesylate

EXPERIMENTAL

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

Drug: Eribulin Mesylate; Device: MRI; Drug: Pre-Medication: Zofran; Drug: Pre-Medication: Decadron

Interventions

Eribulin Mesylate DRUG

Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

Also known as: Halaven

Eribulin Mesylate

MRI DEVICE

An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate

Also known as: Magnetic Resonance Imaging

Eribulin Mesylate

Pre-Medication: Zofran DRUG

Zofran at 8mg orally. Given at the discretion of the treating physician

Eribulin Mesylate

Pre-Medication: Decadron DRUG

decadron at 8mg orally. Given at the discretion of the treating physician

Eribulin Mesylate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Interventions

eribulin; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Paula Silverman
• Organization: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

CTUreferral@UHhospitals.org

1-800-641-2422

Study Officials

• Paula Silverman, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 21, 2015
• Study Start: November 17, 2015
• Primary Completion: July 2, 2018
• Study Completion: July 2, 2020
• Last Updated: July 30, 2020
• Results First Posted: March 3, 2020

Record last verified: 2020-07

Locations

US (2)