Ixabepilone + Carboplatin Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT01075100|
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : December 7, 2016
Last Update Posted : December 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Drug: Ixabepilone Drug: Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Ixabepilone Plus Carboplatin in Patients With Metastatic Breast Cancer: The ECLIPSE Study|
|Study Start Date :||January 2010|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
Experimental: Weekly Ixabepilone +carboplatin
Subjects will receive ixabepilone and carboplatin on Days 1 and 8 of each 21-day cycle.
20 mg/m2 on Days 1 and 8
Other Names:Drug: Carboplatin
carboplatin AUC=2.5 on Days 1 and 8
Other Name: Paraplatin
- Objective Response Rate (ORR) [ Time Frame: 24 months ]
Evaluate the objective response rate calculated as CR+ PR in the population evaluable for response, as well as the 2 subgroups (hormone receptor positive [ER+/PR+/HER2-, ER+/PR-/HER2-, ER-/PR+/HER2-]) and ER-/PR-HER2-, separately).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Clinical Benefit Rate (CBR) [ Time Frame: 24 months ]Clinical benefit rate (CBR) defined as objective response rate (ORR, CR + PR) + SD >= 6 months
- Progression-free Survival (PFS) [ Time Frame: 24 months ]
PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Overall Survival (OS) [ Time Frame: 24 months ]OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
- Time to Response [ Time Frame: 24 months ]For patients who achieve a major objective response (CR or PR) the time to response will be assessed as the date of registration to the date of response.
- Duration of Response [ Time Frame: 30 months ]The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075100
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|Principal Investigator:||Cynthia R Osborne, MD||US Oncology|