Finding studies
Finding studies
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Lead
H. Lee Moffitt Cancer Center and Research Institute
With
OBJECTIVES: * Evaluate the clinical and pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer. * Measure signal transducer and activator of transcription (STAT) activation before and after this neoadjuvant chemotherapy regimen in this patient population. * Correlate response to chemotherapy with STAT activation before and after this neoadjuvant chemotherapy regimen in these patients. * Determine how other potential predictors of response correlate with STAT activation by measuring Bcl-2, Bcl-xL, Bax protein levels, tyrosine kinase levels, growth rate of the tumor, and apoptotic index before and after this neoadjuvant chemotherapy regimen in these patients. * Correlate response to chemotherapy with levels of STAT activation in association with the presence of Bcl-2 proteins and tyrosine kinases, growth rate of the tumor, and apoptotic index in these patients. * Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense fashion in these patients. OUTLINE: Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses. Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 5 years.
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted