Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab and Chemotherapy in Breast Cancer

• Status: Completed
• Trial end date: 2017-10-06
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Bevacizumab

Criteria

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.