Status:
COMPLETED
Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab and Chemotherapy in Breast Cancer
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 6 2017
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01190345
Start Date
May 1 2010
End Date
October 6 2017
Last Update
August 13 2018
Active Locations (3)
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1
Jean-Marc EXTRA, MD
Marseille, France, 13009
2
Jean-Yves PIERGA
Paris, France
3
Hervé CURE
Reims, France