Finding studies
Finding studies
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Lead
UNICANCER
OBJECTIVES: Primary * Evaluate the complete histological response rate in patients with inflammatory HER2-negative breast cancer treated with bevacizumab and concurrent chemotherapy followed by bevacizumab and concurrent hormonal therapy after surgery and radiotherapy. Secondary * Evaluate the progression-fee and overall survival of these patients at 3 and 5 years. * Evaluate the tolerance of bevacizumab in these patients. * Assess circulating metastatic disease before, during, and after treatment. * Assess circulating endothelial cells before, during, and after treatment. * Assess predictive factors of response by genomic and proteomic studies on frozen tumor samples and fluid samples (i.e., serum and plasma). OUTLINE: This is a multicenter study. * Neoadjuvant induction therapy: * Courses 1-4: Patients receive bevacizumab IV over 30-90 minutes, fluorouracil IV, epirubicin hydrochloride IV over 10 minutes, and cyclophosphamide IV over 5 minutes on day 1. * Courses 5-8: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. * Surgery: Patients undergo surgery 4-6 weeks after completion of bevacizumab. * Adjuvant therapy: Beginning 2-4 weeks after surgery, patients undergo radiotherapy for 6 weeks. Patients also receive bevacizumab IV over 30-90 minutes beginning 2-4 weeks after surgery, during the radiotherapy period. Treatment with bevacizumab repeats every 3 weeks for 30 weeks in the absence of disease progression or unacceptable toxicity. Patients who are estrogen receptor- or progesterone receptor-positive (≥ 10% by IHC) receive the following concurrent hormonal therapy beginning in week 7: * Premenopausal patients: Patients receive tamoxifen citrate for 5 years. * Postmenopausal patients: Patients receive aromatase-inhibitor therapy (or tamoxifen citrate if unable to tolerate anti-aromatase therapy) for 5 years. * Perimenopausal patients: Patients receive tamoxifen citrate for 2-3 years and aromatase-inhibitor therapy for 2-3 years OR tamoxifen citrate for 5 years followed by aromatase-inhibitor therapy for 2-3 years (if follicle-stimulating hormone \> 30 IU/L and/or estradiol \< 30 ng/L). After completion of study treatment, patients are followed for at least 3 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted