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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148668
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : January 25, 2013
Last Update Posted : April 9, 2013
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Herceptin
Drug: Navelbine
Drug: Taxotere
Drug: Carboplatin

  Participant Flow

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
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Reporting Groups
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 

  Baseline Characteristics

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
Arm 1 Herceptin/navelbine
Arm 2 Taxotere/carboplatin/herceptin
Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   40   81 
[Units: Years]
Mean (Standard Deviation)
 47.8  (12.6)   48.1  (8.5)   48  (10.7) 
[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

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

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

Responsible Party: Eric Winer, MD, Dana-Farber Cancer Institute Identifier: NCT00148668     History of Changes
Other Study ID Numbers: 03-311
First Submitted: September 7, 2005
First Posted: September 8, 2005
Results First Submitted: December 19, 2012
Results First Posted: January 25, 2013
Last Update Posted: April 9, 2013