Breast Cancer Clinical Trial
Official title:
A Phase I Study of Cisplatin, Paclitaxel, and RAD001 Patients With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Everolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Giving more than one drug (combination chemotherapy) together with
everolimus may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cisplatin,
paclitaxel, and everolimus when given together for the treatment of patients with metastatic
breast cancer.
OBJECTIVES:
Primary
- To establish the safety profile and the maximum tolerated dose of the combination of
cisplatin, paclitaxel, and everolimus in patients with metastatic breast cancer.
Secondary
- To explore the antitumor activity of this regimen, in terms of response rate and time
to progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin intravenously (IV) over 1 hour and paclitaxel IV over 1 hour on
days 1, 8, and 15. Patients receive oral everolimus on days 1, 8, 15, and 21. Courses repeat
every 4 weeks in the absence of disease progression and unaccepted toxicity.
After completion of study therapy, patients are followed at 4 weeks.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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