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Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00209092
First Posted: September 21, 2005
Last Update Posted: March 27, 2015
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.
Collaborators:
Georgia Center for Oncology Research & Education
Sanofi
Information provided by (Responsible Party):
Amelia Zelnak, Emory University
Results First Submitted: March 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Docetaxel
Drug: Capecitabine

  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
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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
  Description
Arm A:Sequential Therapy Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
Arm B:Concurrent Therapy Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Participant Flow:   Overall Study
    Arm A:Sequential Therapy   Arm B:Concurrent Therapy
STARTED   25   26 
COMPLETED   17   24 
NOT COMPLETED   8   2 
Progression of disease                7                1 
Adverse Event                0                1 
Withdrawal by Subject                1                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.
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Reporting Groups
  Description
Arm A:Sequential Therapy Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
Arm B:Concurrent Therapy Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
Total Total of all reporting groups

Baseline Measures
   Arm A:Sequential Therapy   Arm B:Concurrent Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   26   51 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   25   25   50 
>=65 years   0   1   1 
Age, Customized 
[Units: Participants]
Median (Full Range)
 50.8 
 (38 to 63) 
 49.8 
 (29 to 66) 
 50.3 
 (29 to 66) 
Gender 
[Units: Participants]
     
Female   25   26   51 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   25   26   51 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.   [ Time Frame: 1 year ]

2.  Secondary:   Long Term Follow up Data on Recurrence and Survival   [ Time Frame: 2 years ]


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


Results Point of Contact:  
Name/Title: Dr. Amelia Zelnak
Organization: Emory University
phone: 404-778-1900
e-mail: amelia.zelnak@emory.edu


Publications of Results:

Responsible Party: Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier: NCT00209092     History of Changes
Other Study ID Numbers: 1114-2003
First Submitted: September 14, 2005
First Posted: September 21, 2005
Results First Submitted: March 15, 2012
Results First Posted: June 25, 2012
Last Update Posted: March 27, 2015