Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Institut Paoli-Calmettes
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab and Chemotherapy in Breast Cancer
