Spots Global Cancer Trial Database for Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer
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Trial Identification
Brief Title: Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer
Official Title: 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
Study ID: NCT00733408
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Anchorage Oncology Centre, Anchorage, Alaska, United States
Katmai Oncology Group, Anchorage, Alaska, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
Yuma Cancer Center, Yuma, Arizona, United States
Saint Joseph Regional Medical Center, Lewiston, Idaho, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Kalispell Regional Medical Center, Kalispell, Montana, United States
Bend Memorial Clinic, Bend, Oregon, United States
Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States
Evergreen Hospital Medical Center, Kirkland, Washington, United States
Skagit Valley Hospital Regional Cancer Care Center, Mount Vernon, Washington, United States
Group Health Cooperative, Redmond, Redmond, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
Olympic Medical Cancer Care Center, Sequim, Washington, United States
Spokane Valley Cancer Center-Mayfair, Spokane, Washington, United States
Multicare Medical Oncology Hematology, Tacoma, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
Contact Details
Name: Jennifer Specht
Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Role: PRINCIPAL_INVESTIGATOR
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