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
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Sponsor:
US Oncology Research
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
US Oncology Research
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Metastatic Breast Cancer |
Interventions |
Drug: Ixabepilone Drug: Carboplatin |
Enrollment | 103 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Triple Negative | HR Positive |
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ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. | ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. |
Period Title: Overall Study | ||
Started | 49 | 54 |
Completed | 0 | 1 |
Not Completed | 49 | 53 |
Reason Not Completed | ||
Adverse Event | 15 | 18 |
Patient Request | 4 | 4 |
Investigator Request | 2 | 1 |
Disease Progression | 25 | 29 |
Other | 3 | 1 |
Baseline Characteristics
Arm/Group Title | Triple Negative | HR Positive | Total | |
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ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. | ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle. | Total of all reporting groups | |
Overall Number of Baseline Participants | 49 | 54 | 103 | |
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ITT population
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 49 participants | 54 participants | 103 participants | |
55.0 (9.0) | 56.7 (10.6) | 55.9 (9.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 49 participants | 54 participants | 103 participants | |
Female |
49 100.0%
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54 100.0%
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103 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 49 participants | 54 participants | 103 participants |
Caucasian | 33 | 39 | 72 | |
Hispanic | 2 | 2 | 4 | |
Hawaiian | 0 | 1 | 1 | |
Black | 14 | 10 | 24 | |
Asian | 0 | 2 | 2 | |
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 49 participants | 54 participants | 103 participants |
49 | 54 | 103 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Cynthia Osborne |
Organization: | US Oncology Research, McKesson Specialty Health |
Phone: | 214-370-1057 |
EMail: | Cynthia.Osborne@usoncology.com |
Responsible Party: | US Oncology Research |
ClinicalTrials.gov Identifier: | NCT01075100 |
Other Study ID Numbers: |
08007 |
First Submitted: | January 14, 2010 |
First Posted: | February 24, 2010 |
Results First Submitted: | January 12, 2016 |
Results First Posted: | December 7, 2016 |
Last Update Posted: | December 7, 2016 |