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Taxotere and Adriamycin/Cytoxan (AC) Validation in Breast Cancer Patients (TACAC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Mothaffar Rimawi, Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00206518
First received: September 14, 2005
Last updated: May 8, 2017
Last verified: May 2017
Results First Received: February 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Taxotere/Docetaxel
Drug: Adriamycin/Cytoxan
Drug: doxorubicin

  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
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
  Description
A: Taxotere/Docetaxel

Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.

Taxotere/Docetaxel: Taxotere

doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.

B: AC Adriamycin/Cytoxan

In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.

Adriamycin/Cytoxan: Adriamycin/Cytoxan


Participant Flow:   Overall Study
    A: Taxotere/Docetaxel   B: AC Adriamycin/Cytoxan
STARTED   83   84 
COMPLETED   73   78 
NOT COMPLETED   10   6 
Lack of Efficacy                6                4 
Adverse Event                2                1 
Physician Decision                1                0 
Protocol Violation                1                1 



  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.
No text entered.

Reporting Groups
  Description
A: Taxotere/Docetaxel

Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.

Taxotere/Docetaxel: Taxotere

doxorubicin: AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.

B: AC Adriamycin/Cytoxan

In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.

Adriamycin/Cytoxan: Adriamycin/Cytoxan

Total Total of all reporting groups

Baseline Measures
   A: Taxotere/Docetaxel   B: AC Adriamycin/Cytoxan   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   84   167 
Age, Customized 
[Units: Participants]
     
<=50 years   56   49   105 
>50 years   27   35   62 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      83 100.0%      84 100.0%      167 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   21   27   48 
Hispanic   35   34   69 
Black   24   18   42 
Asian   3   5   8 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pathological Tumor Response to Neoadjuvant Chemotherapy (Taxotere and AC)   [ Time Frame: 10 years ]

2.  Secondary:   Disease Relapse   [ Time Frame: 10 years ]

3.  Secondary:   Overall Survival   [ Time Frame: 10 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: Tao Wang
Organization: Baylor College of Medicine
phone: 7137985388
e-mail: taow@bcm.edu



Responsible Party: Mothaffar Rimawi, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00206518     History of Changes
Other Study ID Numbers: H 16039
Study First Received: September 14, 2005
Results First Received: February 2, 2017
Last Updated: May 8, 2017