RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with bevacizumab works in treating women with HER2/neu-negative stage II or stage III breast cancer
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Given IV
Given IV
Given IV
Given IV
Given IV
Correlative studies
Given subcutaneously
University of Nebraska Medical Center
Omaha, Nebraska, United States
Percentage of Participants With Study Drug-associated Adverse Events Leading to Dose Holds or Reductions
This outcome is to measure the feasibility of the of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting in women with stage II and III breast cancer that does not over-express human epidermal growth factor receptor 2 (HER 2)/neu
Time frame: through study completion, an average of 10 months
Count of Participants With Related Serious Adverse Events (SAEs) by NCI Common Toxicity Criteria v3.0
Assess the safety of Avastin in the adjuvant setting particularly regarding cardiac function, wound healing and toxicity of radiation.
Time frame: through study completion, an average of 10 months
Overall Survival as Assessed by the Kaplan and Meier Method
Overall survival as assessed by the Kaplan and Meier method at 5 years
Time frame: Original time frame: Up to 5 years from date of first treatment; study terminated at 2.5 years
Disease-free Survival
Disease-free survival as assessed by the Kaplan and Meier method
Time frame: From the date of first treatment to the date of disease progression/recurrence, second cancer, or death, whichever came first: Original time frame up to 5 years from date of first treatment; study terminated at 2.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.