Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00119262
First received: July 12, 2005
Last updated: April 29, 2014
Last verified: December 2012
Results First Received: April 4, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Interventions: Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Biological: bevacizumab
Drug: paclitaxel
Biological: filgrastim
Biological: pegfilgrastim
Radiation: radiation therapy
Drug: tamoxifen citrate
Drug: aromatase inhibition therapy

  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
E2104 was opened on October 6,2005, and closed on November 6, 2006 with the final accrual of 226 patients.Study participants included Eastern Cooperative Oncology Group (ECOG) entire group, North Central Cancer Treatment Group (NCCTG) entire group and Cancer and Leukemia Group B (CALGB) entire group.

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 (ddBAC > BT > B) Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
Arm B (ddAC > BT > B) Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab

Participant Flow:   Overall Study
    Arm A (ddBAC > BT > B)     Arm B (ddAC > BT > B)  
STARTED     104     122  
Eligible     103     120  
Treated     103     120  
Eligible and Treated     102     119  
COMPLETED     58     64  
NOT COMPLETED     46     58  
Lack of Efficacy                 0                 3  
Withdrawal by Subject                 12                 11  
Adverse Event                 33                 35  
other disease                 0                 2  
ineligble                 1                 2  
others                 0                 5  



  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
Arm A (ddBAC > BT > B) Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
Arm B (ddAC > BT > B) Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
Total Total of all reporting groups

Baseline Measures
    Arm A (ddBAC > BT > B)     Arm B (ddAC > BT > B)     Total  
Number of Participants  
[units: participants]
  103     120     223  
Age  
[units: years]
Median ( Full Range )
  50  
  ( 33 to 76 )  
  50  
  ( 27 to 76 )  
  50  
  ( 27 to 76 )  
Gender  
[units: participants]
     
Female     103     119     222  
Male     0     1     1  
Region of Enrollment  
[units: participants]
     
United States     103     120     223  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Congestive Heart Failure Rate   [ Time Frame: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry ]

2.  Secondary:   Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC)   [ Time Frame: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment ]

3.  Secondary:   Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab   [ Time Frame: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00119262     History of Changes
Other Study ID Numbers: NCI-2012-02977, NCI-2012-02977, U10CA021115, E2104, E2104, U10CA021115
Study First Received: July 12, 2005
Results First Received: April 4, 2011
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration