A Pilot Study of Adjuvant Doxorubicin and Cyclophosphamide Followed by Paclitaxel Plus Sorafenib in Women With Node Positive or High-Risk Early Stage Breast Cancer
Primary Objectives The primary objective is to assess the safety and tolerability of
doxorubicin / cyclophosphamide followed by paclitaxel in combination with sorafenib in
patients with early stage node positive or otherwise high-risk breast cancer.
Secondary Objectives The secondary objectives are to assess activity in the form of
recurrence-free-interval, distant recurrence-free interval,and overall survival in this
pilot study of doxorubicin / cyclophosphamide followed by paclitaxel in combination with
sorafenib in patients with early stage node positive or otherwise high-risk breast cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.
Denise Yardley, M.D.
Sarah Cannon Research Institute
United States: Institutional Review Board
SCRI BRE 112
|Florida Hospital Cancer Institute||Orlando, Florida 32804|
|Consultants in Blood Disorders and Cancer||Louisville, Kentucky 40207|
|Integrated Community Oncology Network||Jacksonville Beach, Florida 32250|
|Methodist Cancer Center||Omaha, Nebraska 68114|
|Peninsula Cancer Institute||Newport News, Virginia 23601|
|Grand Rapids Clinical Oncology Program||Grand Rapids, Michigan 49503|
|Tennessee Oncology, PLLC||Clarksville, Tennessee 37043|
|Chattanooga Oncology Hematology Associates||Chattanooga, Tennessee 37404|