Breast Cancer Clinical Trial
Official title:
Phase I/II Vinorelbine and Sorafenib as Salvage Therapy in Metastatic Breast Cancer
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.
OBJECTIVES:
Primary
- To determine the safety, tolerability, and recommended phase II dose of sorafenib
tosylate when administered in combination with vinorelbine ditartrate in women with
stage IV adenocarcinoma of the breast. (Phase I)
- To evaluate the 4-month progression-free survival rate in patients treated with this
regimen at the maximum tolerated dose. (Phase II)
Secondary
- To determine time to treatment failure in these patients.
- To determine the response rate in these patients.
- To determine the overall survival and progression-free survival of these patients.
- To evaluate the toxicity profile of this regimen.
OUTLINE: This is a phase I, dose-escalation study of sorafenib tosylate followed by a phase
II study.
Patients receive oral sorafenib tosylate on days 1-28 and vinorelbine ditartrate IV on days
1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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