Fulvestrant and Bevacizumab in Treating Patients With Metastatic Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Fulvestrant and bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving fulvestrant together with bevacizumab may be an effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving fulvestrant together with bevacizumab works in treating patients with metastatic breast cancer.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Fulvestrant and Bevacizumab in Patients With Metastatic Breast Cancer Previously Treated With an Aromatase Inhibitor|
- Six-month progression-free survival (PFS) rate [ Designated as safety issue: No ]
- Adverse event profile [ Designated as safety issue: Yes ]
- PFS [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Objective response rate as measured by RECIST criteria, duration of response, and time to disease progression in patients with measurable disease [ Designated as safety issue: No ]
- Time to first cytotoxic agent [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
- Assess the efficacy of fulvestrant and bevacizumab, in terms of 6-month progression-free survival (PFS), in patients with metastatic breast cancer previously treated with an aromatase inhibitor.
- Assess the quality of life of patients treated with this regimen.
- Determine the adverse-event profile in these patients.
- Determine the PFS and overall survival of these patients.
- Determine the confirmed response rate, duration of response, time to treatment failure, and time to first cytotoxic agent in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive fulvestrant intramuscularly on day 1 and bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to every other course, and at the completion of study treatment.
After completion of study treatment, patients are followed every 3-6 months for 5 years.
PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423917
Show 205 Study Locations
|Study Chair:||Winston Tan, MD, FACP||Mayo Clinic|
|Investigator:||Kendrith M. Rowland, MD||Carle Cancer Center at Carle Foundation Hospital|
|Investigator:||Donald W. Northfelt, MD, FACP||Mayo Clinic|
|Investigator:||Michele Yvette Halyard, MD||Mayo Clinic|