Conditions: Breast Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer HER2-negative breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, 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 paclitaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.

Secondary

* To evaluate time to disease progression in patients treated with this regimen.
* To evaluate six-month progression-free survival of patients treated with this regimen.
* To evaluate time to treatment failure in patients treated with this regimen.
* To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
* To evaluate duration of response in patients treated with this regimen.
* To evaluate the tolerability of this regimen in these patients.
* To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks.

Arms:
arm 1: Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15

Interventions: intervention 1: paclitaxel intervention 2: sorafenib tosylate
Intervention descriptions: intervention 1: The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma intervention 2: Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma

Protocol document: