Multi-center, non randomised, open label, non controlled pilot study. Evaluating the treatment of bevacizumab in association with pre-operative chemotherapy, followed by surgery, adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.
Pilot study evaluating the safety and efficacy of adding Bevacizumab to neoadjuvant chemotherapy in patients presenting non metastatic inflammatory breast cancer (IBC). Patients will receive 4 cycles of chemotherapy FEC100 associating Fluorouracil (500 mg/m2), Epirubicin (100 mg/m2), Cyclophosphamide (500 mg/m2) and Bevacizumab 15 mg/kg every at day 1 of ecah 21 days cycle for 4 cycles. Six weeks after the end of neoadjuvant chemotherapy, patients will undergo mastectomy and 4 cycles of Docetaxel (100 mg/m2)as adjuvant chemotherapy +/-Trastuzumab 8 mg/kg for the first cycle then 6mg/kg every 3 weeks for 17 cycles if tumor overexpress Human Epidermal Growth Factor Receptor 2 (HER2). The primary objective of this study is to evaluate the safety and the efficacy, i.e. pathologic complete response (pCR) after 4 cycles of FEC100+Bevacizumab in IBC
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
During neoadjuvant phase: 15 mg/kg, d1 q3w, 4 cycles
Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles
Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles
Institut Salah Azaiz
Bab Saadoun, Tunis Governorate, Tunisia
RECRUITINGpathologic Complete Response (pCR)
Evaluation of the pathologic complete response (pCR) rate among patients treated by 4 cycles of FEC100 and bevacizumab
Time frame: 18 months
Toxicity as assessed by CTCAE v3.0
Evaluation of the safety of administering bevacizumab in the neoadjuvant setting, with particular attention on the incidence of grade 3/4 adverse events
Time frame: 3 and 5 years
Progression-free survival
Time frame: 3 and 5 years
Overall survival
Time frame: 3 and 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles
Adjuvant: 100 mg/m2 q3w, 4 cycles
Adjuvant: 8 mg/kg d1 in the 1st cycle then 6 mg/kg for d1 q3w, 17 cycles if tumor overexpress HER2