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Phase II" Proof of Concept " Trial Evaluating Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab in Combination With Chemotherapy in Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II" Proof of Concept " Trial Evaluating Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab in Combination With Chemotherapy in Breast Cancer

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

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure of the anti-cancer stem cell activity

Outcome Description:

The anti-cancer stem cell (CSC) activity is measured by the amount of Aldehyde dehydrogenase 1/ALDH1+ cells after 4 cycles of treatment compared to the amount before treatment

Outcome Time Frame:

4 months

Safety Issue:


Principal Investigator

Jean-Marc EXTRA, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli-Calmettes


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

AVASTEM/IPC 2009-001



Start Date:

May 2010

Completion Date:

May 2017

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms