Fluorescence Guided Surgery in Breast Cancer

Study Overview
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Brief Summary
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A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.

Official Title
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Phase II, Open-Label Study to Evaluate Safety and Explore Efficacy of Escalating Doses of Bevacizumab-IRDye800CW as an Optical Imaging Agent to Detect Cancer Tissue Delineation During Tumor Resection Surgery in Patients With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Bevacizumab-800CW


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Females aged ≥ 18 years. Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery. Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data. WHO performance score 0-2. Life expectancy greater than 12 weeks Written informed consent has been obtained In the Investigator's opinion, patient is able and willing to comply with all trial requirements. For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal: A negative serum pregnancy test prior to receiving the second generation tracer Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter. Main Exclusion Criteria: Medical or psychiatric conditions that compromise the patient's ability to give informed consent Breast prosthesis in the target breast History of infusion reactions to Bevacizumab or other monoclonal antibody therapies Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment Significant renal or hepatic impairment. Inadequately controlled hypertension with or without current antihypertensive medications. History of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment. Patients receiving anticoagulant therapy with vitamin K antagonists. Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents. Evidence of QT prolongation on pre-treatment ECG (Males >440 ms, Females >450 ms). Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg) | Drug: Bevacizumab-800CW<br>* three days prior to surgery bevacizumab-800CW will be administered<br>* Other names: Bevacizumab-IRDye800CW;|
| Experimental: Part 2<br>In part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group. | Drug: Bevacizumab-800CW<br>* three days prior to surgery bevacizumab-800CW will be administered<br>* Other names: Bevacizumab-IRDye800CW;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor-to-background ratio |  | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events |  | up to two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, image-guided surgery