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Fulvestrant and Bevacizumab in Treating Patients With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00423917
First received: January 16, 2007
Last updated: March 28, 2017
Last verified: March 2017
Results First Received: December 5, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: bevacizumab
Drug: fulvestrant

  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
Fulvestrant + Bevacizumab Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Fulvestrant + Bevacizumab
STARTED   36 
COMPLETED   33 
NOT COMPLETED   3 
Cancel                2 
Ineligible                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.
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Reporting Groups
  Description
Fulvestrant + Bevacizumab Patients receive Fulvestrant 250 mg intramuscularly every 28 days and Bevacizumab 10mg/kg intravenously with a rate-regulating device on days 1 and 15. Loading dose of fulvestrant for the first cycle will consist of an extra 250 mg on day 1 (for total of 500 mg Cycle 1, Day 1). The initial bevacizumab dose will be delivered over 90 minutes. If the first infusion is tolerated without infusion-associated adverse events (fever and/or chills), the second infusion may be delivered over 60 minutes. If the 60-minute infusion is well-tolerated, all subsequent infusions may be delivered over 30 minutes.Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Fulvestrant + Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age 
[Units: Years]
Median (Full Range)
 65 
 (34 to 90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      32  97.0% 
Male      1   3.0% 
Region of Enrollment 
[Units: Participants]
 
United States   33 


  Outcome Measures
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1.  Primary:   Six-month Progression-free Survival (PFS) Rate at 6 Months   [ Time Frame: at 6 months ]

2.  Secondary:   Progression Free Survival   [ Time Frame: Up to 5 years ]

3.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

4.  Secondary:   Quality of Life, as Measured by the Largest Mean Change in LASA Overall QOL and Physical Well-being Items   [ Time Frame: Up to 5 years ]

5.  Secondary:   Objective Response Rate as Measured by RECIST Criteria in Patients With Measurable Disease   [ Time Frame: Up to 5 years ]

6.  Secondary:   Time to First Cytotoxic Agent   [ Time Frame: Up to 5 years ]

7.  Secondary:   Duration of Response/Time to Disease Progression in Patients With Measurable Disease   [ Time Frame: Up to 5 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: Winston Tan MD
Organization: Mayo Clinic
phone: 507/284-1159
e-mail: tan.winston@mayo.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00423917     History of Changes
Other Study ID Numbers: NCCTG-N0539
NCI-2009-00649 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000525570 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: January 16, 2007
Results First Received: December 5, 2016
Last Updated: March 28, 2017