Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Yale University
Information provided by (Responsible Party):
Eric Winer, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00148668
First received: September 7, 2005
Last updated: March 29, 2013
Last verified: March 2013
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Herceptin
Drug: Navelbine
Drug: Taxotere
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
A total of 81 patients were enrolled on the study between 12/2003 and 8/2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
.

Reporting Groups
  Description
Herceptin/Navelbine Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks
Taxotere/Carboplatin/Herceptin Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles

Participant Flow:   Overall Study
    Herceptin/Navelbine     Taxotere/Carboplatin/Herceptin  
STARTED     41     40  
COMPLETED     41     40  
NOT COMPLETED     0     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
Arm 1 Herceptin/navelbine
Arm 2 Taxotere/carboplatin/herceptin
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  41     40     81  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 12.6     48.1  ± 8.5     48  ± 10.7  
Gender  
[units: participants]
     
Female     41     40     81  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     41     40     81  



  Outcome Measures

1.  Primary:   Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer   [ Time Frame: 12 weeks ]


  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 Eric Winer
Organization: Dana-Farber Cancer Institute
phone: 617-632-2335
e-mail: eric_winer@dfci.harvard.edu


No publications provided


Responsible Party: Eric Winer, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00148668     History of Changes
Other Study ID Numbers: 03-311
Study First Received: September 7, 2005
Results First Received: December 19, 2012
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board