Fluorescence Guided Surgery in Breast Cancer - The MARGIN-2 Study (MARGIN-2)
Breast Cancer, Breast Cancer Invasive

About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Patients are females with histologically proven carcinoma of the breast The carcinoma of the breast is a local disease with limited size (but tumor size ≥ 0.5cm) and in the multidisciplinary tumor board meeting breast conserving therapy is advised. Age ≥ 18 years Written informed consent has been obtained Women of childbearing potential (premenopausal women with intact reproductive organs and women less than two years after menopause) require use of effective contraception at least 3 months before administration of the tracer (if not, a negative serum pregnancy test has to be submitted), and they need to be willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent Non palpable breast tumor or prior surgery of this breast Received an investigational drug within 30 days prior to bevacizumab-IRDye800CW History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure or unstable angina within 6 months prior to enrollment Inadequately controlled hypertension with or without current antihypertensive medication Significant renal or hepatic impairment (grade II or higher deviations by CTCAE) History of allergy or infusion reactions bevacizumab or other monoclonal antibodies Pregnant or lactating women Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents Life expectancy < 12 weeks Preoperatively undetectable lymph nodes using SPECT-scan, requiring the use of patent blue
Sites / Locations
- University Medical Center Groningen
- Martini Ziekenhuis
Arms of the Study
Arm 1
Experimental
Fluorescence guided surgery
10 mg bevacizumab-IRDye800CW, to intraoperatively assess possible tumour-positive margins.