The purpose of this study was to determine the effects of the weekly regimen of ixabepilone dosing compared to the once every 3 week dosing regimen in participants with metastatic breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 16 mg/m\^2 was administered as a 1-hour IV continuous infusion on Days 1, 8, and 15 in a 28-day cycle until progressive disease or intolerable toxicity.
Injection, IV, Until progressive disease or intolerable toxicity Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day cycle provided the subject met the retreatment criteria.
Progression-Free Survival (PFS) at 6 Months (6-month PFS Rate): Proportion of Participants Progression Free at 6 Months
PFS at 6 months was defined as proportion of participants who neither progressed nor died before 6 months. Computed using Kaplan-Meier estimates.
Time frame: From the date of randomization to 6-months on study
Median Progression Free Survival
PFS is defined as time interval from the date of randomization to the date of (first) progression or date of death. Participants who progressed or died were counted as events. Participants lost to follow-up were censored as of the last date of contact. Participants who started a new treatment before they progressed were censored as of the date of start of the new treatment. Participants who had not progressed or died were censored at the date of last follow-up. PFS (months) = (End date - date of randomization + 1)/30.4375.
Time frame: From the date of randomization to date of progression, death, or last tumor assessment (maximum participant PFS of 25.7 months)
Overall Response Rate (ORR) Based on Response Criteria in Solid Tumors [RECIST]
ORR is defined as the proportion of responders (complete response \[CR\] + partial response \[PR\] in participants with measurable disease) in that arm among all randomized participants. CR: Disappearance of all evidence of target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions. Measurable disease: Lesions that can be accurately measured in at least one dimension (LD to be recorded) as ≥20 mm with conventional techniques (computed tomography \[CT\], magnetic resonance imaging \[MRI\], X-ray) or as ≥10 mm with spiral CT scan.
Time frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Best Response as Assessed With RECIST
Determined based on the sequence of disease status with corresponding best response. PD=At least a 20% increase in the sum of LD of target lesions in reference to the smallest sum LD recorded or the appearance of 1 or more new lesions; SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD in reference to the smallest sum LD. NE=Participants who discontinued treatment secondary to toxicity or died (either before completion of 1 treatment cycle). Please refer outcome measure 3 for explanation of CR and PR. CR+PR+SD=overall disease control.
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Birmingham Hematology & Oncology Associates Llc
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, United States
Southwest Cancer Care
Murrieta, California, United States
Florida Cancer Institute
Hudson, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers Of Florida, P.A
Ocoee, Florida, United States
Cancer Care & Hematology Specialists Of Chicagoland
Niles, Illinois, United States
Central Indiana Cancer Centers
Carmel, Indiana, United States
...and 47 more locations
Time frame: Assessed at 12-week intervals until disease progression (to a maximum follow-up for tumor response of 26.3 months)
Overall Survival (OS)
Survival was measured as the date of randomization to the date of death. Participants who were alive at the time of the database lock or lost to follow-up were censored at the last known alive date. The distribution of overall survival was analyzed via the Kaplan Meier method in each arm. Survival time (months) = (End date - date of randomization + 1)/30.4375
Time frame: From the date of randomization to date of death (maximum participant OS of 26.3 months)
Time to Response
Time to response is defined as the time from the start of treatment until the first (confirmed) CR or PR was recorded. Time to response was computed only for participants whose best response was PR or CR. CR: Disappearance of all target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (LD) of all target lesions with reference to the baseline sum LD.
Time frame: From the date of first dose to date of first PR or CR assessment ( maximum participant time to response of 8.3 months)
Duration of Response
Duration of overall response was defined as the period from the time first PR or CR was recorded until the first date of documented PD or death. Duration of response was computed for participants whose best response was either PR or CR. Participants who neither relapsed nor died were censored on the date of their last tumor assessment. Kaplan-Meier method was used to estimate the duration of response. Refer to outcome measures 3 and 4 for CR, PR, and PD.
Time frame: From the date of first PR or CR assessment to date of progression, death, or last tumor assessment (maximum participant duration of response of 17.4 months)
Incidence of All Grades of Peripheral Neuropathy
All events of peripheral neuropathy were assessed and graded per National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE)Version 3. CTC Grade (GR) 1=Mild; GR2=Moderate; GR3=Severe or medically significant, not immediately life-threatening; and GR4=Life-threatening. All treatment-related and not related Neuropathy and Peripheral Neuropathy were included; serious adverse events (SAEs) were not included.
Time frame: Assessed from the date of first study dose until at least 30 days after the last dose of study drug. Median time on study therapy was 12 weeks (range: 4-60 weeks for 16 mg/m^2 arm; 3-87 weeks for 40 mg/m^2 arm).