Finding studies
Finding studies
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Lead
University of Nebraska
With
PRIMARY OBJECTIVES: I. To assess the feasibility of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting. II. To assess the safety of Avastin in the adjuvant setting particularly regarding cardiac function, wound healing and toxicity of radiation. SECONDARY OBJECTIVES: I. To determine the effect of Avastin on immunity, especially Vascular endothelial growth factor A (VEGF-A) upregulation of myeloid-derived suppressor cells (MDSC) and suppression of T-Cells. II. To determine the effect of therapy on numbers of myeloid derived suppressor cells and compare the humoral and cellular response to p53 in breast cancer patients treated with the same chemotherapy. III. Patients will be followed for freedom from tumor progression and survival. OUTLINE: COURSES 1-4: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 1. Treatment repeats every 2 weeks for 4 courses in the absence of unacceptable toxicity or disease progression. COURSES 5-7: Patients receive paclitaxel IV and gemcitabine hydrochloride IV on day 1 and pegfilgrastim SC on day 1. Patients also receive bevacizumab IV on day 1 in courses 5-7. Treatment repeats every 2 weeks for 4 courses in the absence of unacceptable toxicity or disease progression. COURSES 8-16: Patients receive bevacizumab IV alone on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of unacceptable toxicity or disease progression. After course 8, patients may undergo radiotherapy and hormone therapy, if clinically indicated. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 5 years.
Age
19–any
Sex
FEMALE
Healthy volunteers
Not accepted
