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A Study to Evaluate Safety, Tolerability and Efficacy of Eribulin Mesylate in Treating Adult Females With Locally Advanced or Metastatic Breast Cancer

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: NCT03583944
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate clinical and laboratory safety of eribulin mesylate in treating participants with locally advanced or metastatic breast cancer, who have progressed after at least one regimen of chemotherapy which has included anthracycline and taxane therapy.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Eribulin Mesylate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Marketing Trial (Phase IV) on the Safety, Tolerability And Efficacy of Eribulin Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Actual Study Start Date : March 28, 2018
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eribulin Mesylate 1.23 mg
Participants will receive eribulin mesylate 1.23 mg intravenous (IV) infusion, given over 2 - 5 minutes on Days 1 and 8 of 21 days cycle for a total of 6 cycles.
 Drug: Eribulin Mesylate
Eribulin mesylate IV infusion.
Other Name: Halaven


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months) ]
    Clinical Safety will be assessed by recording the adverse events (AEs) and serious AEs (SAEs) observed during the study period and its relation to the study medication. AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect.

  2. Number of Participants with TEAEs Related to Laboratory Parameters [ Time Frame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months) ]
    AE is defined as any untoward medical occurrence in a participant administered a treatment of medicinal product. An SAE is any untoward medical occurrence that at any dose results in death, results in life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or results in a congenital anomaly/birth defect. TEAEs are defined as those events that started on or after the date and time of administration of the first dose of study drug and those events that were present prior to the administration of the first dose of study drug and increased in severity during the study.


Secondary Outcome Measures :
  1. Objective Tumor Response [ Time Frame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months) ]
    Radiological confirmation of objective response rate (ORR) will be assessed by the Response Evaluation Criteria in Solid Tumors(RECIST)criteria version 1.1. The response would be assessed based on the four response parameters -complete response(CR), partial response(PR), stable disease(SD), progressive disease(PD).CR is defined as disappearance of all target lesions. PR is seen when there is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameters. When there is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of longest diameters since the treatment started then, the response is evaluated as SD.PD is seen when there is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started or the appearance of one or more new lesions.

  2. Objective Response Rate (ORR) [ Time Frame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months) ]
    ORR measures the response rate using the formula - CR+PR/ (number of eligible participants)*100. CR is defined as disappearance of all target lesions. PR is seen when there is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameters.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants with locally advanced or metastatic breast cancer.
  2. Participants must have progressed after at least after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an Anthracycline and a Taxane unless participants who are not suitable for these treatments.
  3. Participants must have documented disease progression within or on 6 months from their last anti-cancer therapy.
  4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (<=) 2.

  5. Participants must have normal organ and marrow function as defined below:

    • Absolute neutrophil count greater than (>) 1,500 per microliter (/mcL)
    • Hemoglobin >10.0 gram per deciliter (g/dL)
    • Platelets >100,000/mcl
    • Serum total bilirubin less than (<) 1.5*upper limit of normal (ULN)
    • Serum aspartate aminotransferase (AST) (Serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (Serum glutamic pyruvic transaminase [SGPT]) <3*ULN or <5*ULN in the presence of liver metastases
    • Serum creatinine <1.5 mg/dL.
  6. Females in reproductive age willing to follow adequate barrier contraceptive measures during the conduct of study.

Exclusion Criteria:

  1. Hypersensitivity to the active substance or any of the excipients.
  2. Participants who have received chemotherapy, radiation, or biological therapy within two weeks, or hormonal therapy within one week before study treatment start, or any investigational drug within four weeks before study treatment start.
  3. Participants receiving any other investigational agents.
  4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, or other comorbid condition that investigator believes may compromise participant's condition.
  5. Participants requiring concurrent anti-cancer therapy during the study period.
  6. Participants with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting study treatment.
Contacts and Locations
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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): NCT03583944


Locations
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Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Medical Director Eisai Inc.
More Information
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03583944    
Other Study ID Numbers: E7389-M065-401
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
E7389
Tumors, Breast
Breast Cancer
Breast Carcinoma
Neoplasms, Breast
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases