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.
Interventional
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.
18 Months
Yes
Denise Yardley, M.D.
Study Chair
Sarah Cannon Research Institute
United States: Institutional Review Board
SCRI BRE 112
NCT00544167
May 2007
April 2011
Name | Location |
---|---|
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 |