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Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Daiichi Sankyo UK Ltd.
Triple Negative Breast Cancer Foundation
Information provided by (Responsible Party):
Andres Forero, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01307891
First received: March 1, 2011
Last updated: August 14, 2017
Last verified: August 2017
Results First Received: May 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Triple Negative Breast Cancer
Stage IV Breast Cancer
Metastatic Breast Cancer
Interventions: Drug: Abraxane alone
Drug: Abraxane + Tigatuzumab

  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
No text entered.

Reporting Groups
  Description
Abraxane + Tigatuzumab Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
Abraxane Alone Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).

Participant Flow:   Overall Study
    Abraxane + Tigatuzumab   Abraxane Alone
STARTED   42   22 
COMPLETED   39   21 
NOT COMPLETED   3   1 
Progressive Disease                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.
No text entered.

Reporting Groups
  Description
Abraxane + Tigatuzumab Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
Abraxane Alone Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
Total Total of all reporting groups

Baseline Measures
   Abraxane + Tigatuzumab   Abraxane Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   22   64 
Age 
[Units: Participants]
Count of Participants
     
<=18 years   0   0   0 
Between 18 and 65 years   35   18   53 
>=65 years   7   4   11 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   42   22   64 
Male   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   1   0   1 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   14   6   20 
White   26   16   42 
More than one race   0   0   0 
Unknown or Not Reported   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   42   22   64 


  Outcome Measures
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1.  Primary:   Objective Response Rate   [ Time Frame: Baseline to 6 months ]

2.  Secondary:   Number of Participants With Serious Adverse Events   [ Time Frame: Baseline to 6 months ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Baseline through 24 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: Andres Forero, M.D.
Organization: University of Alabama at Birmingham
phone: 205-934-7167
e-mail: aforero@uab.edu



Responsible Party: Andres Forero, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01307891     History of Changes
Other Study ID Numbers: F101004001 (UAB1028)
TBCRC 019 ( Other Identifier: The Translational Breast Cancer Research Consortium )
Study First Received: March 1, 2011
Results First Received: May 24, 2017
Last Updated: August 14, 2017