The purpose of this study is to evaluate anti-cancer stem cell (CSC) activity (measured by the amount of Aldehyde dehydrogenase 1/ALDH1+ cells before and after treatment) of pre-operative bevacizumab in combination with conventional chemotherapy in breast cancer receiving neo-adjuvant treatment, compared to a control arm receiving chemotherapy alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Patients receive on day 1 of each cycle : bevacizumab 15 mg/kg (8 injections in total).
no bevacizumab
Jean-Marc EXTRA, MD
Marseille, France
Jean-Yves PIERGA
Paris, France
Hervé CURE
Reims, France
Measure of the anti-cancer stem cell activity
The anti-cancer stem cell (CSC) activity is measured by the amount of Aldehyde dehydrogenase 1/ALDH1+ cells after 4 cycles of treatment compared to the amount before treatment
Time frame: 4 months
Evaluation of the safety of the treatment
Evaluation of the safety of the treatment at each cycle, estimated by the number of patients with clinical and biological adverse events coded according to the CTCAE
Time frame: 8 months
Evaluation of the disease-free survival, recurrence-free survival and overall survival
The disease-free survival, recurrence-free survival and overall survival are calculated from the inclusion to the time of the event
Time frame: 5 years
Evaluation of the pathological complete response rate
Evaluation of the pathological complete response rate according to the classification of Sataloff
Time frame: 8 months
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