Efficacy and Safety of Bevacizumab in the Neodjuvant Treatment of Inflammatory Breast Cancer

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Multi-center, non randomised, open label, non controlled pilot study. Evaluating the treatment of bevacizumab in association with pre-operative chemotherapy, followed by surgery, adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association Tunisienne de lutte Contre le Cancer
• Collaborators: Hoffmann-La Roche; Sanofi
• Treatments: Bevacizumab; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Trastuzumab

Criteria

Inclusion Criteria:

• • Patients must have signed a written informed consent form prior to any study specific procedures,

• Women,

• 20 years or older,

• Performance status < 2 (ECOG),

• Histologically confirmed inflammatory breast cancer T4d any N,

• hormonal Status known,

• no metastases according to the last TNM classification,

• adequate hematologic function :

• absolute neutrophil count ≥ 1 500/mm3

• Platelets ≥ 100 000/mm3

• Hemoglobin ≥ 9 g/dL

• adequate liver function :

• ASAT and ALAT < à 3 ULN

• Alkaline Phosphatase < 5 ULN

• Total bilirubin < 1,5 ULN, o

• adequate kidney function :

• creatinine < 1,5 x normal or creatinine Clearance ≥ 50ml/min (according to the cockcroft and Gault formula)

• Urine Dipstick for proteinuria < 2+ patients who have proteinuria ≥ 2 + on dipstick urinalysis at baseline should undergo a 24 hours urine collection and must demonstrate ≤ 1 g of protein in 24 hours,

• adequate coagulation and cardiac function :

• Prothrombin ratio ≥ 70 % and,

• Prothrombin time ≤ 1,5 upper limit of normal (ULN) within 7 days prior to enrolment

• Left Ventricular ejection fraction (LVEF) ≥ 55 %

Exclusion Criteria:

• Patients of childbearing potential with a positive pregnancy test (serum or urine) prior to enrollment

• Patients who are either not post-menopausal, or surgically sterile, not using "effective contraception" (the definition of "effective contraception" will be based on the judgment of the investigator)

• Patients who are pregnant or breastfeeding

• Patient considered socially or psychological unable to comply with the treatment and the required medial follow-up,

• Concurrent participation in another clinical trial or treatment with any other anticancer agent during the protocol specified period

• Patients unwilling or unable to sign and date an Ethics Committee (EC)/ Institutional Review Board (IRB)-approved patient informed consent form

• Patients unwilling or unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

• Non inflammatory breast cancer with lymphatic skin permeation, Metastases,

• Bilateral breast cancer

• Distant metastases (stage IV)

• History of another cancer other than adequately treated carcinoma in situ of the cervix uteri, basal or squamous cell skin cancer

• Prior anti tumor therapy (surgery, radiotherapy, chemotherapy, hormonal treatment and targeted therapy) except treatments given for carcinoma in situ of the cervix uteri, basal or squamous cell skin cancer

• History or evidence of inherited bleeding diathesis or coagulopathy,

• History of thrombotic disorders within the last 6 months prior to enrollment (i.e. cerebrovascular accident, transient ischemic attacks, subarachnoid hemorrhage),

• Uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)with or without any anti-hypertensive medication ; patients with high initial blood pressure are eligible if entry criteria are met after initiation or adjustment of anti-hypertensive medication,

• Any of the following within 6 months prior to enrollment:

myocardial infarction, severe/unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4)

• Severe resting dyspnea due to complications or oxygen dependency,

• Diabetic patient treated with oral anti-diabetics or insulin with an underlying cardiopathy at ultrasound,

• Any other severe acute illness such as active uncontrolled infections that would preclude the safe administration of study therapy at the time of the enrolment

• Other severe underlying medical conditions, which could impair the ability to participate in the study

• Major surgery, significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during study treatment,

• Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion,

• Non-healing wound, active peptic ulcer or bone fracture,

• History of abdominal fistula, diagnosed with a trachea-oesophageal fistula or any grade 4 non gastro-intestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment,