Oxidized Glutathione (NOV-002), Doxorubicin, Cyclophosphamide, and Docetaxel in Treating Women With Newly Diagnosed Stage IIB, or Stage IIIC Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00499122
First received: July 10, 2007
Last updated: July 25, 2014
Last verified: August 2013
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Doxorubicin hydrochloride
Drug: Glutathione disulfide NOV-002
Procedure: conventional surgery

  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
NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel

Cyclophosphamide :

Doxorubicin hydrochloride :

conventional surgery :

Docetaxel :

Glutathione disulfide NOV-002 :


Participant Flow:   Overall Study
    NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel  
STARTED     41  
COMPLETED     41  
NOT COMPLETED     0  



  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
NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel

Cyclophosphamide :

Doxorubicin hydrochloride :

conventional surgery :

Docetaxel :

Glutathione disulfide NOV-002 :


Baseline Measures
    NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel  
Number of Participants  
[units: participants]
  41  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     34  
>=65 years     7  
Gender  
[units: participants]
 
Female     41  
Male     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     10  
Not Hispanic or Latino     31  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     13  
White     26  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     41  



  Outcome Measures

1.  Primary:   Percentage of Participants Achieving Pathologic Complete Response   [ Time Frame: 4 years ]

2.  Secondary:   To Define the Safety Profiles of Preoperative Administration of NOV-002 in Combination With Doxorubicin, Cyclophosphamide Followed by Docetaxel.   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   To Correlate Serum Protein Glutathionylation With Clinical and Pathologic Responses   [ Time Frame: 4 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: Alberto Montero MD
Organization: UM/Sylvester Comprehensive Cancer Center
phone: 305-243-3771
e-mail: amontero2@med.miami.edu


Publications of Results:

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00499122     History of Changes
Other Study ID Numbers: UMIAMI-20071167, MUSC-101072, MUSC-HR-17111
Study First Received: July 10, 2007
Results First Received: January 18, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration