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Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

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ClinicalTrials.gov Identifier: NCT02581839
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE October 14, 2015
First Posted Date  ICMJE October 21, 2015
Last Update Posted Date April 12, 2019
Actual Study Start Date  ICMJE November 17, 2015
Actual Primary Completion Date July 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
Proportion of subjects with Central Nervous System (CNS) Progression free survival (PFS) [ Time Frame: At 12 weeks ]
The study team will assess the proportion of subjects 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02581839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Objective Response Rate (RR) [ Time Frame: up to 2 years from start of treatment ]
    The study team will calculate the proportion (and 95% CI) of the patients with complete and partial response
  • Average duration of CNS response [ Time Frame: up to 2 years from start of treatment ]
    The study team will calculate the duration of CNS response
  • Number of patients treated with eribulin who experienced serious adverse events [ Time Frame: up to 2 years from start of treatment ]
    The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.
  • Number of patients with CBR [ Time Frame: At 12 weeks ]
    The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)
  • Systemic Disease Response Rate [ Time Frame: up to 2 years from start of treatment ]
    The study team will estimate systemic disease response rate (and 95% CI) and perform a Kaplan-Meier analysis for systemic response in this patient population
  • Average overall survival (OS) [ Time Frame: up to 2 years from start of treatment ]
    The study team will generate a Kaplan-Meier curve of OS.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2015)
  • Objective Response Rate (RR) [ Time Frame: from beginning of first treatment to subject death or disease progression, up to 2 years ]
    The study team will calculate the proportion (and 95% CI) of the patients with complete and partial response
  • Average duration of CNS response [ Time Frame: from beginning of first treatment to subject death or disease progression, up to 2 yeas ]
    The study team will calculate the duration of CNS response
  • Toxicity [ Time Frame: from beginning of first treatment to subject death or disease progression, up to 2 years ]
    The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin.
  • Number of patients with CBR [ Time Frame: At 12 weeks ]
    The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR)
  • Systemic Disease Response Rate [ Time Frame: from beginning of first treatment to subject death or disease progression, up to 2 years ]
    The study team will estimate systemic disease response rate (and 95% CI) and perform a Kaplan-Meier analysis for systemic response in this patient population
  • Average overall survival (OS) [ Time Frame: from beginning of first treatment to subject death or disease progression, up to 2 years ]
    The study team will generate a Kaplan-Meier curve of OS.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
Official Title  ICMJE Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
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.
Detailed Description

Primary Objectives:

To determine the 3-month central nervous system (CNS)-progression free survival (PFS) for patients with metastatic breast cancer with brain metastases treated with eribulin mesylate.

Secondary Objective(s):

1. Estimate CNS complete and partial response rates (CR and PR) and duration of CNS response in this patient population.

2 Evaluate toxicity in patients with breast cancer with brain metastases treated with eribulin mesylate.

3 Estimate clinical benefit rate (CBR) at 3 months in breast cancer patients with brain metastases treated with eribulin mesylate. (CBR is the sum of CR, PR and stable disease at 3 months).

4 To estimate systemic disease (extra cranial) response rate and duration of systemic response in this patient population.

5 Overall survival in this patient population.

Design:

This is a phase II study that will require patients to evaluate the primary objective (CNS PFS at 3 months). Study patients will have a baseline brain MRI and a second MRI at 12 weeks to evaluate disease.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Breast Cancer
  • Brain Metastases
Intervention  ICMJE
  • Drug: Eribulin Mesylate
    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.
    Other Name: Halaven
  • Device: MRI
    An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
    Other Name: Magnetic Resonance Imaging
  • Drug: Pre-Medication: Zofran
    Zofran at 8mg orally. Given at the discretion of the treating physician
  • Drug: Pre-Medication: Decadron
    decadron at 8mg orally. Given at the discretion of the treating physician
Study Arms  ICMJE Experimental: Eribulin Mesylate
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
Interventions:
  • Drug: Eribulin Mesylate
  • Device: MRI
  • Drug: Pre-Medication: Zofran
  • Drug: Pre-Medication: Decadron
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 19, 2018)
9
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2015)
20
Estimated Study Completion Date  ICMJE July 2, 2020
Actual Primary Completion Date July 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02581839
Other Study ID Numbers  ICMJE CASE7113
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paula Silverman, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP