Adjuvant Doxorubicin, Cyclophosphamide Followed by Avastin Given With Paclitaxel and Gemcitabine for Stage II and III Breast Cancer That Does Not Over-express HER-2/Neu
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.
I. To determine the effect of Avastin on immunity, especially VEGF-A upregulation of 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
III. Patients will be followed for freedom from tumor progression and survival.
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
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
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility as assessed by the proportion of patients with study drug-associated adverse events leading to dose holds or reductions summarized using percentages and 95% confidence intervals
At study drug-associated adverse events leading to dose holds or reductions
University of Nebraska
United States: Institutional Review Board
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center||Omaha, Nebraska 68198-7680|