Phase II Randomized Study of Sorafenib Compared to Placebo When Administered in Combination With Aromatase Inhibitors for Postmenopausal Women With Metastatic Breast Cancer
OBJECTIVES:
Primary
- To compare the progression-free survival of postmenopausal women with estrogen
receptor- and/or progesterone receptor-positive metastatic breast cancer treated with
sorafenib tosylate vs placebo and letrozole, anastrozole, or exemestane.
Secondary
- To compare the overall survival and time to treatment failure of patients treated with
these regimens.
- To compare the objective tumor response rate and duration of response in patients
treated with these regimens.
- To assess the adverse event profile of sorafenib tosylate in combination with aromatase
inhibitors in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior aromatase
inhibitor therapy (yes vs no) and line of endocrine therapy for metastatic disease
(first-line vs second-line). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral sorafenib tosylate twice daily and oral letrozole,
anastrozole, or exemestane once daily on days 1-28.
- Arm II: Patients receive oral placebo twice daily and oral letrozole, anastrozole, or
exemestane once daily on days 1-28.
In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study therapy, patients are followed periodically for up to 5 years.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Progression-free survival
No
Vivek Roy, MD
Study Chair
Mayo Clinic in Florida
United States: Food and Drug Administration
RC0731
NCT00573755
November 2007
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |