ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02581839
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

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

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 : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate
Actual Study Start Date : November 17, 2015
Actual Primary Completion Date : January 15, 2018
Estimated Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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. Given at the discretion of the treating physician

Drug: Pre-Medication: Decadron
decadron at 8mg orally. Given at the discretion of the treating physician




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. Number of patients treated with eribulin who experienced serious adverse events [ 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.

  4. 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)

  5. 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

  6. 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.



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, Older Adult)
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 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.

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


Locations
United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
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

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02581839     History of Changes
Other Study ID Numbers: CASE7113
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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