We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov Menu

Adj TC + Herceptin Early Stage Breast Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 28, 2007
Last Update Posted: November 3, 2016
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.
Information provided by (Responsible Party):
US Oncology Research
Results First Submitted: January 12, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Taxotere
Drug: Cytoxan
Drug: Herceptin

  Participant Flow
  Hide Participant Flow

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
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
STARTED   493 
Adverse Event                44 
Patient Request                21 
Investigator Request                2 
Disease Progression                1 
Lost to Follow-up                1 
Other                13 

  Baseline Characteristics
  Hide 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.
ITT population

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 55.1  (10.1) 
[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
  Show All Outcome Measures

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
  Hide 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
No text entered.

  More Information
  Hide 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. 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 )
First Submitted: June 27, 2007
First Posted: June 28, 2007
Results First Submitted: January 12, 2016
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016