Bevacizumab and Letrozole in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer That Cannot Be Removed By Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others
      interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Estrogen can cause the growth of
      breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the
      amount of estrogen the body makes. Giving bevacizumab together with letrozole may be an
      effective treatment for locally advanced or metastatic breast cancer.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with letrozole
      works in treating postmenopausal women with locally advanced or metastatic breast cancer that
      cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the safety and feasibility of bevacizumab in combination with letrozole in
           postmenopausal women with estrogen receptor- and/or progesterone receptor-positive,
           unresectable, locally advanced or metastatic breast cancer.

      Secondary

        -  Determine the response rate (partial response [PR] and complete response [CR]) in
           patients treated with this regimen.

        -  Determine the clinical benefit rate (PR, CR, and stabilization of disease for ≥ 24
           weeks) in patients treated with this regimen.

        -  Determine the time to progression in patients treated with this regimen.

        -  Determine the duration of response in patients treated with this regimen.

        -  Determine the proportion of patients treated with this regimen who have stable disease
           for ≥ 24 weeks.

        -  Determine the molecular profile of the patient's breast tumor and explore the
           relationship between these molecular characteristics and response or resistance to
           treatment.

        -  Obtain serial measurements (pre- and post-treatment) of circulating endothelial cells
           and epithelial cells and explore the relationship between these cells and serum markers
           of angiogenesis and response to treatment.

      OUTLINE: This is a multicenter study.

      Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral letrozole once daily on
      days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable
      toxicity.

      PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; letrozole
Intervention type(s): Biological; Drug
Intervention MeSH terms: Bevacizumab; Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer