21
Participants
Start Date
April 30, 2000
Primary Completion Date
December 31, 2002
Study Completion Date
October 31, 2003
doxorubicin hydrochloride
Patients receive doxorubicin IV continuously over 72 hours on days 1-3 of course 1. For all subsequent courses, patients receive doxorubicin as in course 1. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
semaxanib
For all subsequent courses, after course 1 patients SU5416 IV over 1 hour twice weekly (on days 1 and 4) beginning on week 2 of course 2. Treatment repeats every 21 days for 5 courses in the absence of disease progression or unacceptable toxicity.
conventional surgery
Patients undergo a modified radical mastectomy.
radiation therapy
Patients undergo radiotherapy to the chest wall and regional lymph nodes.
tamoxifen
Patients with estrogen or progesterone receptor positive disease receive oral tamoxifen for 5 years after radiotherapy.
Ireland Cancer Center at University Hospitals Case Medical Center, Cleveland
National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER