Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab and Chemotherapy in Breast Cancer

Breast Cancer Clinical Trial

— AVASTEM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190345
• Other study ID #: AVASTEM/IPC 2009-001
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: October 6, 2017

Study information

• Verified date: August 2018
• Source: Institut Paoli-Calmettes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 6, 2017
• Est. primary completion date: July 24, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab
Patients receive on day 1 of each cycle : bevacizumab 15 mg/kg (8 injections in total).
• no bevacizumab
no bevacizumab

Locations

Country	Name	City	State
France	Jean-Marc EXTRA, MD	Marseille
France	Jean-Yves PIERGA	Paris
France	Hervé CURE	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the anti-cancer stem cell activity	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	4 months
Secondary	Evaluation of the safety of the treatment	Evaluation of the safety of the treatment at each cycle, estimated by the number of patients with clinical and biological adverse events coded according to the CTCAE	8 months
Secondary	Evaluation of the disease-free survival, recurrence-free survival and overall survival	The disease-free survival, recurrence-free survival and overall survival are calculated from the inclusion to the time of the event	5 years
Secondary	Evaluation of the pathological complete response rate	Evaluation of the pathological complete response rate according to the classification of Sataloff	8 months

External Links

•   institut Paoli-Calmettes web site