A Phase II Open-Label Study of Sorafenib Plus Fulvestrant as Salvage Therapy for Hormone Receptor Positive Metastatic Breast Cancer Failing Prior Aromatase Inhibitor Treatment
OBJECTIVES:
Primary
- To investigate the clinical activity of sorafenib tosylate and fulvestrant, as
determined by a 4-month progression-free survival rate, in patients with hormone
receptor-positive locally advanced or metastatic breast cancer that progressed after
prior treatment with an aromatase inhibitor.
Secondary
- To determine the objective response rate in patients treated with this regimen.
- To determine the median time to progression in patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the overall survival of patients treated with this regimen.
- To establish the safety and tolerability profile of this regimen in these patients.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Patients also
receive fulvestrant intramuscularly on days 1 and 15 of course 1 and on day 1 of all
subsequent courses. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed at 28-56 days.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Progression-free Survival at 4 Months
Progression-free survival rate is defined as the proportion of subjects who are progression free (CR, PR and SD) at 4 months after initiating treatment with sorafenib plus fulvestrant. Complete Response (CR):Disappearance of all target (both measurable and evaluable)lesions. Partial Response (PR):At least a 30% decrease in the sum of the longest diameter (LD) of both measurable and evaluable target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease(PD).
4 months after initiating treatment with sorafenib plus fulvestrant.
No
Stephen Chui, MD
Principal Investigator
OHSU Knight Cancer Institute
United States: Food and Drug Administration
CDR0000601002
NCT00722072
July 2008
July 2012
Name | Location |
---|---|
OHSU Knight Cancer Institute | Portland, Oregon 97239 |