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Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

This study has been terminated.
Sponsor:
Collaborators:
Georgia Center for Oncology Research & Education
Sanofi
Information provided by (Responsible Party):
Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier:
NCT00209092
First received: September 14, 2005
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
Results First Received: March 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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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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  
Number of Participants  
[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
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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 Plus Capecitabine for 8 Cycles)in Patients With Early Stage Breast Cancer.   [ Time Frame: 1 year ]
  Show Outcome Measure 1

2.  Secondary:   Long Term Follow up Data on Recurrence and Survival   [ Time Frame: 2 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


No publications provided


Responsible Party: Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier: NCT00209092     History of Changes
Other Study ID Numbers: 1114-2003
Study First Received: September 14, 2005
Results First Received: March 15, 2012
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board