Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305825
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2006-03-21
Brief Title:
Bevacizumab and Letrozole in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer That Cannot Be Removed By Surgery
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase II Study of Letrozole in Combination With Bevacizumab in Patients With Estrogen Receptor- andor Progesterone Receptor-Positive Unresectable Locally Advanced andor Metastatic Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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- andor 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 patients 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
Primary
Determine the safety and feasibility of bevacizumab in combination with letrozole in postmenopausal women with estrogen receptor- andor 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSF-H6961-24611-02 | None | None | None |
| UCSF-037518 | None | None | None |