Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00148668
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : January 25, 2013
Last Update Posted : April 9, 2013
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

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
Enrollment 81
Recruitment Details A total of 81 patients were enrolled on the study between 12/2003 and 8/2008.
Pre-assignment Details  
Arm/Group Title Herceptin/Navelbine Taxotere/Carboplatin/Herceptin
Hide Arm/Group Description Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles
Period Title: Overall Study
Started 41 40
Completed 41 40
Not Completed 0 0
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description Herceptin/navelbine Taxotere/carboplatin/herceptin Total of all reporting groups
Overall Number of Baseline Participants 41 40 81
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 40 participants 81 participants
47.8  (12.6) 48.1  (8.5) 48  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 40 participants 81 participants
Female
41
 100.0%
40
 100.0%
81
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants 40 participants 81 participants
41 40 81
1.Primary Outcome
Title Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
Hide Description Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Please Note that in Arm 2, the number of participants analyzed is equal to 39, which differs from the Number of Participants reported in the baseline measure (N= 40) because one participant withdrew her consent, so was not evaluable.
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:
Herceptin/navelbine
Taxotere/carboplatin/herceptin
Overall Number of Participants Analyzed 41 39
Measure Type: Number
Unit of Measure: percentage of participants
17 31
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description Herceptin/navelbine Taxotere/carboplatin/herceptin
All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/41 (12.20%)      5/40 (12.50%)    
Blood and lymphatic system disorders     
Neutropenia   4/41 (9.76%)  4 4/40 (10.00%)  4
Febrile Neutropenia   0/41 (0.00%)  0 1/40 (2.50%)  1
Hepatobiliary disorders     
SGPT (ALT)   1/41 (2.44%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/41 (65.85%)      25/40 (62.50%)    
Blood and lymphatic system disorders     
Dehydration   0/41 (0.00%)  0 2/40 (5.00%)  2
Gastrointestinal disorders     
Diarrhea   1/41 (2.44%)  1 2/40 (5.00%)  2
Anorexia   0/41 (0.00%)  0 2/40 (5.00%)  2
General disorders     
Fatigue   1/41 (2.44%)  1 2/40 (5.00%)  2
Hepatobiliary disorders     
SGOT (AST)   3/41 (7.32%)  3 0/40 (0.00%)  0
SGPT (ALT)   4/41 (9.76%)  4 0/40 (0.00%)  0
Immune system disorders     
Leukocytes   6/41 (14.63%)  6 7/40 (17.50%)  7
Neutropenia   11/41 (26.83%)  11 5/40 (12.50%)  5
Febrile Neutropenia   1/41 (2.44%)  1 2/40 (5.00%)  2
Reproductive system and breast disorders     
Irregular Menses   0/41 (0.00%)  0 3/40 (7.50%)  3
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr Eric Winer
Organization: Dana-Farber Cancer Institute
Phone: 617-632-2335
EMail: eric_winer@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Eric Winer, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov 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