A Phase 4 interventional study of Eribulin Mesylate in Breast Neoplasms, sponsored by Eisai Inc.. Completed at 18 sites in India. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Eisai Inc. · Phase 4, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must have normal organ and marrow function as defined below:
Exclusion Criteria:
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.
Also known as: Halaven
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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.
Time frame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Number of Participants with TEAEs Related to Laboratory Parameters
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.
Time frame: Baseline up to 30 days after last dose of study drug or at discontinuation (approximately up to 17 months)
Objective Tumor Response
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.
Time frame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
Objective Response Rate (ORR)
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.
Time frame: Baseline to first date of documented CR, PR, SD, or PD, up to end of study treatment (approximately up to 17 months)
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Eisai Inc.