Ixabepilone + Carboplatin Metastatic Breast Cancer
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|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|
|Actual Primary Completion Date :||June 2013|
|Actual 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
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|