At a glance
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Phase I/II Vinorelbine and Sorafenib as Salvage Therapy in Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating sorafenib tosylate and vinorelbine ditartrate for Breast Cancer. Completed, enrolled 46 participants across 2 sites.
Detailed Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with vinorelbine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of sorafenib when given together with vinorelbine and to see how well they work in treating women with stage IV breast cancer.
Study Details
Timeline
Interventions
Dose level 1 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 2 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 3 = 200 mg by mouth in the am and 400 mg by mouth in the pm on days 1-28 of a 28 day cycle. Dose level 4 = 400 mg by mouth two times a day on days 1-28 of a 28 day cycle.
Dose level 1 = 20 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 2 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 3 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 4 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle.