Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
UNC Lineberger Comprehensive Cancer Center
With
OBJECTIVES: Primary * Compare the overall response rate in women with estrogen receptor-negative, progesterone receptor-negative, human epidermal growth factor receptor 2 (HER2)-nonoverexpressing metastatic breast cancer treated with cetuximab with vs without carboplatin. Secondary * Compare the time to disease progression in patients treated with these regimens. * Correlate downstream effects of epidermal growth factor receptor (EGFR) inhibitor on Mitogen-activated protein kinases (MAPK), Protein kinase B (AKT), monoclonal antibody Ki-67 (Ki67), and EGFR-dependent signaling, proliferation, and apoptosis with toxicity and response in patients with accessible tumors treated with these regimens. * Determine the changes in biomarkers and gene expression in circulating tumor cells during treatment. * Compare the overall survival rate in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive cetuximab IV over 60-120 minutes once a week. * Arm II: Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment in arm I may cross over to arm II. Blood samples are collected periodically throughout study for correlative biomarker analysis by Immunohistochemistry (IHC) and gene expression analysis. After completion of study treatment, patients are followed every 4 months.
Age
18–120
Sex
FEMALE
Healthy volunteers
Not accepted
