Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-24 @ 9:11 PM
NCT ID:
NCT00404404
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as ABI-007, work in different ways stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving ABI-007 together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II is studying how well giving ABI-007 together with bevacizumab works in treating women with recurrent or metastatic breast cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the activity of paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane\^®) and bevacizumab, in terms of progression-free survival and response rate, in women with recurrent or metastatic breast cancer.
Secondary
* Determine the toxicity profile of this regimen in these patients.
* Determine the feasibility of this regimen in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation (ABI-007; Abraxane\^®) IV over 30 minutes on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Study:
NCT00404404
Study Brief:
Protocol Section:
NCT00404404