Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer
- 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.
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete histologic response rate
Patrice Viens, MD
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)