ABI-007 and Bevacizumab in Treating Women With Recurrent or Metastatic Breast Cancer

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT00404404
• Lead Sponsor: Premiere Oncology

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-28
• Status Verified: 2007-04
• Last Update Submitted: 2013-12-17
• Last Update Posted: 2013-12-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival as measured by RECIST criteria at 1 and 2 years

Secondary Outcome Measures

Name	Time	Method
Response rate measured every 3 courses during treatment
Overall survival
Time to progression
Disease-free survival
Toxicity

Trial Locations

Locations (1)

Premiere Oncology; 🇺🇸 Santa Monica, California, United States