We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00050167
First Posted: November 27, 2002
Last Update Posted: August 29, 2011
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.
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: July 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Paclitaxel
Drug: Docetaxel
Drug: Capecitabine

  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
Recruitment period from November 20, 2002 to July 2, 2008. All recruitment done at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Planned accrual was 930 participants, only 601 were found eligible.

Reporting Groups
  Description
Weekly Paclitaxel (WP) Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
Docetaxel and Capecitabine (DX) Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.

Participant Flow:   Overall Study
    Weekly Paclitaxel (WP)   Docetaxel and Capecitabine (DX)
STARTED   302   301 
COMPLETED   301   300 
NOT COMPLETED   1   1 
not eligible not invasive                1                1 



  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.
No text entered.

Reporting Groups
  Description
Weekly Paclitaxel (WP) Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
Docetaxel and Capecitabine (DX) Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
Total Total of all reporting groups

Baseline Measures
   Weekly Paclitaxel (WP)   Docetaxel and Capecitabine (DX)   Total 
Overall Participants Analyzed 
[Units: Participants]
 302   301   603 
Age 
[Units: Years]
Median (Full Range)
 50 
 (42 to 57) 
 50 
 (42 to 57) 
 50 
 (42 to 57) 
Gender 
[Units: Participants]
     
Female   302   301   603 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   302   301   603 


  Outcome Measures

1.  Primary:   Percentage of Participants With Reoccurrence   [ Time Frame: Median of 50 months ]

2.  Secondary:   Proportion of Participants With Pathological Complete Response   [ Time Frame: 7 Years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes   [ Time Frame: 7 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Aman Buzdar, M.D./Professor
Organization: UT MD Anderson Cancer Center
e-mail: agmadrig@mail.mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00050167     History of Changes
Other Study ID Numbers: ID01-580
First Submitted: November 25, 2002
First Posted: November 27, 2002
Results First Submitted: July 7, 2011
Results First Posted: August 5, 2011
Last Update Posted: August 29, 2011