Clinical trial NCT01190345 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: bevacizumab, no bevacizumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility 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.