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Adj TC + Herceptin Early Stage Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00493649
First received: June 27, 2007
Last updated: September 15, 2016
Last verified: September 2016
Results First Received: January 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Taxotere
Drug: Cytoxan
Drug: Herceptin

  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
TC+H This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care.

Participant Flow:   Overall Study
    TC+H
STARTED   493 
COMPLETED   411 
NOT COMPLETED   82 
Adverse Event                44 
Patient Request                21 
Investigator Request                2 
Disease Progression                1 
Lost to Follow-up                1 
Other                13 



  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
TC+H docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)

Baseline Measures
   TC+H 
Overall Participants Analyzed 
[Units: Participants]
 493 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.1  (10.1) 
Gender 
[Units: Participants]
 
Female   493 
Male   0 
Race/Ethnicity, Customized 
[Units: Participants]
 
Caucasian   414 
Black   36 
Hispanic   27 
Asian   12 
Indian   1 
Other   3 
Region of Enrollment 
[Units: Participants]
 
United States   493 


  Outcome Measures
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1.  Primary:   Disease-free Survival (DFS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.   [ Time Frame: 2 years ]

2.  Secondary:   Overall Survival (OS) Rate at 2 Years in TOP2A-amplified and in TOP2A-nonamplified HER2+ ESBC Patients Treated With TC+H.   [ Time Frame: 2 years ]

3.  Secondary:   DFS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.   [ Time Frame: 2 years ]

4.  Secondary:   OS by cMyc Expression in This Population of HER2+ ESBC Patients Treated With TC+H.   [ 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:  
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. Stephen E Jones
Organization: US Oncology Research, McKesson Specialty Health
phone: 832-381-7580
e-mail: steve.jones@usoncology.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00493649     History of Changes
Other Study ID Numbers: 06-038
11270 ( Other Identifier: Sanofi-Aventis )
Study First Received: June 27, 2007
Results First Received: January 12, 2016
Last Updated: September 15, 2016