This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens.
This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously treated with 2 to 5 chemotherapy regimens. The study will be conducted in 3 Phases: a Pretreatment Phase (screening visit), a Treatment Phase (starting with Cycle 1 Day 1), and a Posttreatment Phase (End of treatment visit and survival follow up). Participants may remain on study drug as long as they demonstrate clinical benefit or until intercurrent illness, unacceptable toxicity, or disease progression occurs, until the participant withdraws consent, or death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes biweekly on Day 1 and Day 15 of each 28-day cycle.
Facility #1
Denver, Colorado, United States
Facility #1
Columbia, Maryland, United States
Facility #1
Omaha, Nebraska, United States
Objective Response Rate (ORR) by Investigator Assessment
ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) measured by response evaluation criteria in solid tumors (RECIST) 1.1. CR defined as disappearance of all target lesions (a short diameter is less than \[\<\] 10 millimeter \[mm\] if it exists in a lymph node). PR defined as at least 30 percent (%) decrease in the sum of the long diameter (LD) of all target lesions, as compared with Baseline summed LD.
Time frame: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)
Disease Control Rate (DCR) by Investigator Assessment
DCR was defined as the percentage of participants who had BOR of CR, PR, or stable disease (SD) measured by RECIST 1.1. CR defined as disappearance of all target lesions (a short diameter is \<10 mm if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD defined as reduction in tumor volume of less than 50% or an increase in the volume of 1 or more measurable lesions of less than 25% without the appearance of any new lesions which was neither tumor shrinkage corresponding to PR nor tumor expansion corresponding to disease progression. SD must be achieved at greater than equal to (\>=) 7 weeks after the first eribulin administration to be considered BOR.
Time frame: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)
Progression-Free Survival (PFS) by Investigator Assessment
PFS was defined as the time from date of first dose of study drug to the date of disease progression or death, whichever occurred first.
Time frame: From first dose of study drug until intercurrent illness, unacceptable toxicity, disease progression, or until the participant withdrew consent (approximately up to 2.3 years)
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Facility #1
Albany, New York, United States
Facility #1
Portland, Oregon, United States
Facility #1
Dallas, Texas, United States
Facility #2
Dallas, Texas, United States
Facility #1
Houston, Texas, United States
Facility #1
San Antonio, Texas, United States
Facility #1
Tyler, Texas, United States
...and 2 more locations
Overall Survival (OS)
OS was defined as the time from date of first dose of study drug until date of death from any cause.
Time frame: From date of first dose of study drug administration until date of death from any cause (approximately up to 2.3 years)
Feasibility Rate
Feasibility rate is defined as the percentage of participants completing the first 2 and 4 cycles (1 cycle = 28 days) of eribulin mesylate treatment (4 and 8 doses) without requiring dose delay greater than (\>) 5 days or reduction due to adverse event (AE).
Time frame: Cycle 2 Day 28 and Cycle 4 Day 28 ( cycle length=28 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study drug (Baseline) up to 30 days after last dose of study drug (approximately up to 2.3 years)