Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments bevacizumab, no bevacizumab
Phase phase 2
Target VEGF
Sponsor Institut Paoli-Calmettes
Start date May 2010
End date May 2017
Trial size 75 participants
Trial identifier NCT01190345, AVASTEM/IPC 2009-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bevacizumab 15 mg/kg on day 1 of each cycle : 4 cycles of 5-fluorouracil 500 mg/m² IV + epirubicin 100 mg/m² IV + cyclophosphamide 500 mg/m² IV (FEC100) every 21 days and 4 cycles of docetaxel 100 mg/m² IV every 21 days. Patients with HER2+ disease will receive trastuzumab (8 mg/kg (IV then 6 mg/kg, every 21 days), which will be started with docetaxel and administered for a total duration of 54 weeks, 18 injections.
bevacizumab avastin
Patients receive on day 1 of each cycle : bevacizumab 15 mg/kg (8 injections in total).
(Active Comparator)
4 cycles 5-fluorouracil 500 mg/m² IV + epirubicin 100 mg/m² IV + cyclophosphamide 500 mg/m² IV of (FEC100) every 21 days and 4 cycles of docetaxel 100 mg/m² IV every 21 days. Patients with HER2+ disease will receive trastuzumab (8 mg/kg (IV then 6 mg/kg, every 21 days), which will be started with docetaxel and administered for a total duration of 54 weeks, 18 injections.
no bevacizumab
no bevacizumab

Primary Outcomes

Measure
Measure of the anti-cancer stem cell activity
time frame: 4 months

Secondary Outcomes

Measure
Evaluation of the safety of the treatment
time frame: 8 months
Evaluation of the disease-free survival, recurrence-free survival and overall survival
time frame: 5 years
Evaluation of the pathological complete response rate
time frame: 8 months

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Phase II" Proof of Concept " Trial Evaluating Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab in Combination With Chemotherapy in Breast Cancer
Principal investigator Jean-Marc EXTRA, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Institut Paoli-Calmettes.