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Ixabepilone + Carboplatin Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01075100
First Posted: February 24, 2010
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
US Oncology Research
Results First Submitted: January 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Ixabepilone
Drug: Carboplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Triple Negative 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.
HR Positive 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.

Participant Flow:   Overall Study
    Triple Negative   HR Positive
STARTED   49   54 
COMPLETED   0   1 
NOT COMPLETED   49   53 
Adverse Event                15                18 
Patient Request                4                4 
Investigator Request                2                1 
Disease Progression                25                29 
Other                3                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population

Reporting Groups
  Description
Triple Negative 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.
HR Positive 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 Total of all reporting groups

Baseline Measures
   Triple Negative   HR Positive   Total 
Overall Participants Analyzed 
[Units: Participants]
 49   54   103 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.0  (9.0)   56.7  (10.6)   55.9  (9.9) 
Gender 
[Units: Participants]
     
Female   49   54   103 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Caucasian   33   39   72 
Hispanic   2   2   4 
Hawaiian   0   1   1 
Black   14   10   24 
Asian   0   2   2 
Region of Enrollment 
[Units: Participants]
     
United States   49   54   103 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: 24 months ]

2.  Secondary:   Clinical Benefit Rate (CBR)   [ Time Frame: 24 months ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 24 months ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: 24 months ]

5.  Secondary:   Time to Response   [ Time Frame: 24 months ]

6.  Secondary:   Duration of Response   [ Time Frame: 30 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Cynthia Osborne
Organization: US Oncology Research, McKesson Specialty Health
phone: 214-370-1057
e-mail: Cynthia.Osborne@usoncology.com



Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT01075100     History of Changes
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