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
I. The primary objective is progression free survival.
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).
INDUCTION THERAPY: Patients receive paclitaxel albumin-stabilized nanoparticle formulation
intravenously (IV) once weekly for 24 weeks and bevacizumab IV over 30-90 minutes once every
2 weeks for 24 weeks 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 2 weeks 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.
Baseline, every 8 weeks and at follow up
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Providence Alaska Medical Center||Anchorage, Alaska 99508|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Bozeman Deaconess Hospital||Bozeman, Montana 59715|
|Wenatchee Valley Medical Center||Wenatchee, Washington 98801-2028|
|Katmai Oncology Group||Anchorage, Alaska 99508-4627|
|Cascade Cancer Center||Kirkland, Washington 98034-3013|
|Evergreen Hospital Medical Center||Kirkland, Washington 98033|
|Multicare Health System||Tacoma, Washington 98415|
|Overlake Hospital Medical Center||Bellevue, Washington 98004|
|St. Joseph Regional Medical Center||Lewiston, Idaho 83501|
|Skagit Valley Hospital Regional Cancer Care Center||Mount Vernon, Washington 98274|
|Olympic Medical Cancer Care Center||Sequim, Washington 98384|
|Anchorage Oncology Center||Anchorage, Alabama|
|Northwest Healthcare: Kalispell Regional Medical Center||Kallispell, Alabama|
|Overlake Cancer Center||Bellevue, Washington|
|Columbia Basin Hematology & Oncology PLLC||Kennewick, Washington 99336|