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NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Miami
ClinicalTrials.gov Identifier:
NCT00499122
First received: July 10, 2007
Last updated: April 3, 2017
Last verified: April 2017
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Doxorubicin
Drug: NOV 002

  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 Chemotherapy
  • NOV-002:

    • Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
    • Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
    • Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
  • Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
  • Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
  • Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1

Participant Flow:   Overall Study
    NOV-002 and Chemotherapy
STARTED   41 
COMPLETED   39 
NOT COMPLETED   2 
Withdrawal by Subject                2 



  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 Chemotherapy
  • NOV-002:

    • Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
    • Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
    • Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
  • Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
  • Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
  • Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1

Baseline Measures
   NOV-002 and Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      34  82.9% 
>=65 years      7  17.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      41 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      10  24.4% 
Not Hispanic or Latino      31  75.6% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   4.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      13  31.7% 
White      26  63.4% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   41 


  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving Pathologic Complete Response   [ Time Frame: About 7 months ]

2.  Secondary:   Definition of the Safety Profiles of Protocol Therapy   [ Time Frame: Up to 30 days Post-Last Dose of Protocol Therapy, About 7 months ]

3.  Secondary:   The Correlation of Serum Protein Glutathionylation With Clinical and Pathologic Responses   [ Time Frame: About 7 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
ClinicalTrials.gov Identifier: NCT00499122     History of Changes
Other Study ID Numbers: 20071167
MUSC-101072 ( Other Identifier: Medical University of South Carolina )
MUSC-HR-17111 ( Other Identifier: Medical University of South Carolina )
Study First Received: July 10, 2007
Results First Received: January 18, 2013
Last Updated: April 3, 2017