A Phase I/II Trial of BAY 43-9006 (Sorafenib) in Combination With Anastrozole in Patients With Metastatic Breast Cancer
I. Determine the clinical benefit rate of sorafenib in combination with anastrazole in women
with estrogen receptor- and/or progesterone receptor-positive metastatic breast cancer.
II. Determine the recommended phase II dose of sorafenib when administered with anastrozole
in these patients.
I. Determine the toxic effects of this regimen in these patients. II. Determine the changes
in Raf-MAPK and VEGF-signaling pathways in tumor tissue and stroma before and after
treatment with this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of sorafenib.
PHASE I: Patients receive oral sorafenib twice daily and oral anastrozole once daily on days
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of sorafenib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.
PHASE II: Patients receive sorafenib at the MTD and anastrozole as in phase I.
After completion of study treatment, patients are followed every 4-8 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response + Partial Response + Stable Disease > 24 Weeks
Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking. A patient has clinical benefit from treatment if CR + PR + SD > 24 weeks.
Lombardi Comprehensive Cancer Center at Georgetown University
United States: Food and Drug Administration
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