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Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer

This study has been terminated.
(Low enrollment and there is insufficient data to publish.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01207102
First Posted: September 22, 2010
Last Update Posted: December 15, 2014
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:
Celgene Corporation
Information provided by (Responsible Party):
Duke University
Results First Submitted: December 8, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Abraxane
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
No text entered.

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
Abraxane, Carboplatin

Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle

Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days

Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days


Participant Flow:   Overall Study
    Abraxane, Carboplatin
STARTED   10 
COMPLETED   0 
NOT COMPLETED   10 
Withdrawal by Subject                5 
Adverse Event                2 
progression                2 
Withdrawal by Treating Physician                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.
No text entered.

Reporting Groups
  Description
Abraxane, Carboplatin

Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle

Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days

Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days


Baseline Measures
   Abraxane, Carboplatin 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.5  (8.1) 
Gender 
[Units: Participants]
 
Female   10 
Male   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   7 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   2 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   3 
China   7 


  Outcome Measures
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1.  Primary:   PFS   [ Time Frame: PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first ]

2.  Secondary:   To Assess the Safety and Tolerability of a Combination Regimen of Weekly Abraxane® and Carboplatin to Treat Women With "Triple Negative" Stage IV Metastatic Breast Cancer   [ Time Frame: 2 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Kimberly Blackwell
Organization: Duke University Medical Center
phone: 919-6681748
e-mail: black034@mc.duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01207102     History of Changes
Other Study ID Numbers: Pro00019321
First Submitted: September 10, 2010
First Posted: September 22, 2010
Results First Submitted: December 8, 2014
Results First Posted: December 15, 2014
Last Update Posted: December 15, 2014