Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab and Chemotherapy in Breast Cancer
This trial is active, not recruiting.
|Treatments||bevacizumab, no bevacizumab|
|Start date||May 2010|
|End date||May 2017|
|Trial size||75 participants|
|Trial identifier||NCT01190345, AVASTEM/IPC 2009-001|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Measure of the anti-cancer stem cell activity
time frame: 4 months
Evaluation of the safety of the treatment
time frame: 8 months
Evaluation of the disease-free survival, recurrence-free survival and overall survival
time frame: 5 years
Evaluation of the pathological complete response rate
time frame: 8 months
Female participants at least 18 years old.
Inclusion Criteria: - Women older than 18 ys - Primary breast cancer treated in the neoadjuvant setting (synchronous metastatic disease are eligible) - Primary breast tumor accessible to initial biopsy - White Blood Count > 3.000/µl and Absolute neutrophil count ≥ 1.500/µl AND platelets ≥ 100 x 109/L AND Hemoglobin ≥ 9 g/dL, Serum creatinine ≤ 150µm/l• Urine dipstick for proteinuria < 2+. Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours, Total bilirubin ≤ 1.5 ULN and ASAT < 2.5 ULN AND ALAT < 1.5 ULN (2.5 if liver metastasis), Adequate coagulation function: International normalized ratio (INR) ≤ 1.5 and TCA ≤ 1.5 x ULN - Left ventricular ejection fraction (LVEF) ≥ 55% (isotopic or - ultrasound methods) - Karnofsky Index > 1 ; Performance status 0 to 1 - Patients must have signed a written informed consent form prior to any study specific screening procedures - Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen. Exclusion Criteria: - Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) relapsing within the 5 years before study entry - Known contra-indication to anticancer compounds used - Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) or history of hypertensive encephalopathy - History of inherited diathesis or recent thrombotic events - Non-healing wound, active peptic ulcer or bone fracture. - Major surgery or significant traumatic injury within 28 days prior to study treatment start - History of abdominal fistula, trachea-oesophageal fistula or urinary fistula - Use of Non Steroid Anti Inflammatory or full dose anticoagulants or antiaggregation treatments within 10 days - Pregnancy and breast feeding, premenopausal patient and no effective contraception - Brain metastasis. - Any unstable severe disease such as : uncontrolled cardiac or vascular disease, uncontrolled hemorrhagy, uncontrolled neuropsychiatric disorders, including dementia, uncontrolled infection or any severe disorders that may preclude study participation - Patient considered geographically, socially or psychologically unable to comply with the treatment and the required medical follow-up.
|Official title||Phase II" Proof of Concept " Trial Evaluating Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab in Combination With Chemotherapy in Breast Cancer|
|Principal investigator||Jean-Marc EXTRA, MD|
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