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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Eribulin mesylate IV infusion.
HEMATO-ONCOLOGY CLINIC Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India
HealthCare Global Enterprises Ltd
Bangalore, Karnataka, India
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.
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Srinivasam Cancer Care Multispecialty Hospitals India Pvt Ltd
Bangalore, Karnataka, India
KR Hospital Mysore Medical College
Mysore, Karnataka, India
Tata Memorial Hospital Department of Oncology
Mumbai, Maharashtra, India
HCG NCHRI Cancer Centre
Nagpur, Maharashtra, India
Lokmanya Hospital
Pune, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India
Deep Hospital
Ludhiana, Punjab, India
...and 8 more locations
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)