We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

This study is currently recruiting participants.
Verified April 2017 by Case Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02581839
First Posted: October 21, 2015
Last Update Posted: April 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  Purpose
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.

Condition Intervention Phase
Metastatic Breast Cancer Brain Metastases Drug: Eribulin Mesylate Device: MRI Drug: Pre-Medication: Zofran Drug: Pre-Medication: Decadron Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Actual Study Start Date: November 17, 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: September 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Drug: Pre-Medication: Decadron
decadron at 8mg orally

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 <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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581839


Contacts
Contact: Paula Silverman, MD 216-844-8510 paula.silverman@uhhospitals.org

Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Paula Silverman, MD    216-844-8510    paula.silverman@uhhospitals.org   
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Manmeet S. Ahluwalia, MD, FACP    216-444-6145    ahluwam@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Paula Silverman, MD University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02581839     History of Changes
Other Study ID Numbers: CASE7113
First Submitted: October 14, 2015
First Posted: October 21, 2015
Last Update Posted: April 10, 2017
Last Verified: April 2017

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

Keywords provided by Case Comprehensive Cancer Center:
eribulin
central nervous system
CNS
Eribulin Mesylate
Halaven

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Ondansetron
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors