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Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
Genentech, Inc.
New Hampshire Oncology-Hematology PA
Lowell General Hospital
Hartford Hospital
Information provided by (Responsible Party):
Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00670982
First received: April 29, 2008
Last updated: March 29, 2013
Last verified: March 2013
Results First Received: February 15, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: bevacizumab
Drug: vinorelbine
Drug: trastuzumab

  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
Patients were enrolled between May 2008 and March 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
.

Reporting Groups
  Description
First Line Treatment Patients with no prior therapy for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every 2 weeks and vinorelbine(25mg/m2) intravenously once per week, and trastuzumab (4 mg/kg) intravenously once per week
Second Line Treatment Patients with 1 prior line for metastatic breast cancer will receive bevacizumab(10mg/kg) intravenously every two weeks, vinorelbine (25mg/m2) intravenously once per week, and trastuzumab(4 mg/kg) intravenously once per week.

Participant Flow:   Overall Study
    First Line Treatment     Second Line Treatment  
STARTED     22     7  
COMPLETED     22     7  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
First Line Treatment Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week
Second Line Treatment Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
Total Total of all reporting groups

Baseline Measures
    First Line Treatment     Second Line Treatment     Total  
Number of Participants  
[units: participants]
  22     7     29  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     22     7     29  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  51.5  ± 8     46.7  ± 6.9     50.3  ± 7.9  
Gender  
[units: participants]
     
Female     22     7     29  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     22     7     29  



  Outcome Measures
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1.  Primary:   Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.   [ Time Frame: 1 year ]

2.  Secondary:   Objective Response Rate   [ Time Frame: 1 year ]

3.  Secondary:   Progression-free Survival   [ Time Frame: 3 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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Harold J. Burstein, MD
Organization: Dana-Farber Cancer Institute
phone: 617-632-2335
e-mail: hal_burstein@dfci.harvard.edu


No publications provided


Responsible Party: Harold J. Burstein, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00670982     History of Changes
Other Study ID Numbers: 07-214
Study First Received: April 29, 2008
Results First Received: February 15, 2013
Last Updated: March 29, 2013
Health Authority: United States: Institutional Review Board