NCT00733408

Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer

Combined Targeted Therapies for Triple Negative Advanced Breast Cancer - A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy With Bevacizumab and Erlotinib

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with metastatic breast cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can prevent cancer growth by blocking the ability of cancer cells to grow and spread. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial evaluates a maintenance treatment with erlotinib and bevacizumab after Nab-paclitaxel and bevacizumab which may control cancer growth with biologic therapies.

Detailed description

PRIMARY OBJECTIVES: I. Progression free survival. SECONDARY OBJECTIVES: I. Response rate. II. Overall survival. III. Safety and toxicity. IV. Exploratory biomarkers will be assessed as potential predictors of response to treatment including: expression of epidermal growth factor receptor (EGFR) and secreted protein acidic and rich in cysteine (SPARC) in the primary tumor and changes in levels of circulating tumor cells (CTCs) and circulating endothelial cells (CECs). OUTLINE: INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients achieving complete response, partial response, or stable disease after completion of induction therapy will receive bevacizumab IV over 30-90 minutes once every 14 or 21 days and erlotinib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up per physician discretion.

Conditions

• Estrogen Receptor-negative Breast Cancer
• HER2-negative Breast Cancer
• Progesterone Receptor-negative Breast Cancer
• Recurrent Breast Cancer
• Stage IV Breast Cancer
• Triple-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel albumin-stabilized nanoparticle formulation	Given IV
BIOLOGICAL	bevacizumab	Given IV
DRUG	erlotinib hydrochloride	Given PO

Timeline

• Start date: 2008-04-23
• Primary completion: 2017-07-05
• Completion: 2017-09-28
• First posted: 2008-08-13
• Last updated: 2018-12-04
• Results posted: 2018-12-04

Locations

17 sites across 1 country: United States