The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center (when more than 1 hospital or medical school team work on a medical research study) study evaluating the effectiveness and safety of trabectedin in 3 subpopulations of breast cancer participants: Group A: triple negative profile for estrogen receptor, progesterone receptor and human estrogen receptor, Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carrier. Participants will receive trabectedin 1.3 milligram per square meter (mg/m\^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hour every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Efficacy will be primarily evaluated by percentage of participants with confirmed objective response by independent external review and Investigators assessment. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
Dexamethasone 4 mg orally 24 hrs and 12 hrs before study drug infusion on Day -1, followed by dexamethasone 20 mg intravenously 30 minutes before study drug infusion on Day 1, followed by dexamethasone 4 mg orally 24, 36, 48, 60 and 72 hrs after the start of study drug infusion on Day 1 to 3.
Trabectedin 1.3 mg/m\^2 intravenous infusion over 3-hrs every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks.
Unnamed facility
Sedona, Arizona, United States
Percentage of Participants With Confirmed Objective Response (OR) by Independent External Review (IER)
Percentage of participants with confirmed objective response will be based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR is defined as disappearance of all target lesions. PR is those with at least 30 percent decrease in the sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. IER will be done to re-examine all Investigator assessed outcomes.
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Percentage of Participants With Confirmed Objective Response (OR) by Investigators' Assessment
Percentage of participants with objective response based assessment of confirmed CR or confirmed PR according to RECIST. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. The CR is defined as disappearance of all target lesions. The PR is those with at least 30 percent decrease in the sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Duration of Response (DR) by Independent Expert Review (IER)
Duration of Response is considered as time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as: (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that will be subsequently confirmed plus 1) divided by 30.44. DR will be calculated for the subgroup of participants with a confirmed objective tumor response. IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.
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Unnamed facility
Denver, Colorado, United States
Unnamed facility
Torrington, Connecticut, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Westminster, Maryland, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Columbia, Missouri, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
Amsterdam, New York, United States
...and 23 more locations
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Duration of Response (DR) by Investigators' Assessment
Duration of Response is considered as time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response is calculated as: (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that will be subsequently confirmed plus 1) divided by 30.44. The DR will be calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Progression-Free Survival (PFS) by Independent Expert Review (IER)
PFS is defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS is calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression will be determined from radiological image (where data meet the criteria for progressive disease \[PD\]). IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Progression-Free Survival (PFS) by Investigators' Assessment
PFS is defined as the time in months from start of study treatment to first documentation of objective tumor progression or death due to any cause whichever comes first. PFS is calculated as (first event date minus the date of first dose of study medication plus 1) divided by 30.44. Tumor progression will be determined from radiological image (where data meet the criteria for progressive disease \[PD\]). IER will be done to re-examine all Investigator assessed outcomes and to provide an independent assessment of response and progression date.
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Number of Participants With Changes in Tumor Volume
Three dimensional analysis will be used to measure changes in tumor volume.
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)
Number of Participants With Changes in Tumoral Radiological Density
Three dimensional analysis will be used to measure changes in tumoral radiological density.
Time frame: Baseline up to progressive disease or death, assessed every 6 weeks (up to 90 weeks)