Bevacizumab and Letrozole in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer That Cannot Be Removed By Surgery
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Letrozole in Combination With Bevacizumab in Patients With Estrogen Receptor- and/or Progesterone Receptor-Positive Unresectable Locally Advanced and/or Metastatic (Stage IV) Breast Cancer|
- Safety [ Designated as safety issue: Yes ]
- Feasibility [ Designated as safety issue: No ]
- Response rate (complete response and partial response) [ Designated as safety issue: No ]
- Clinical benefit rate (complete response, partial response, and stable disease for at least 24 weeks) [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Duration of response [ Designated as safety issue: No ]
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00305825
|United States, California|
|UCSF Comprehensive Cancer Center|
|San Francisco, California, United States, 94115-1710|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Hope S. Rugo, MD||University of California, San Francisco|