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
- breast cancer / mamma carcinoma1000629110006295
- Registration Number
- NL-OMON42239
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 26
1. Females aged >= 18 years.
2. Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
3. Tumor size >= 5 mm (0, 5 cm) diameter according to anatomical imaging data.
4. WHO performance score 0-2.
5. Life expectancy greater than 12 weeks
6. Written informed consent has been obtained
7. In the Investigator*s opinion, patient is able and willing to comply with all trial requirements
8. A negative serum pregnancy test within 2 weeks prior to receiving the second generation tracer
9. Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
1. Medical or psychiatric conditions that compromise the patient*s ability to give informed consent
2. Breast prosthesis in the target breast
3. History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
5. Unresolved chronic non-hematological toxicity higher than NCI-CTC grade 2
6. Participation in a clinical study involving an investigational drug or device within 30 days prior to the start of treatment
7. Significant renal or hepatic impairment.
8. Scheduled elective surgery, with the exception of the breast surgical procedure, or other procedures requiring general anesthesia during the trial.
9. Inadequately controlled hypertension with or without current antihypertensive medications.
10. History of myocardial infarction (MI), TIA, CVA, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
11. Patients receiving anticoagulant therapy with vitamin K antagonists.
12. Patients receiving Class IA (e.g. Quinidine, Procanamide) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
13. Evidence of QT prolongation on pre-treatment ECG (Males >440 ms, Females >450 ms).
14. Magnesium, potassium and calcium levels below LLN which is regarded clinically relevant with regards to study participation.
15. Preoperatively undetectable lymphnodes using 99m-TC SPECT-scan that leads to the need of using Patent Blue intraoperatively.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Tumor to Background Ratios (TBR) calculated from images taken intraoperatively<br /><br>and ex vivo from bread loaf slices of the excised specimen.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Assess the safety of the second generation conjugate at all doses tested.<br /><br>• Compare conventional histopathological margin assessment with margin<br /><br>assessment using the fluorescent signal<br /><br>• Confirm if fluorescent signal corresponds to tumor tissue<br /><br>• Explore fluorescence intensity ex vivo in tumor and surrounding tissue</p><br>