This pilot clinical trial studies how well zirconium Zr 89 bevacizumab positron emission tomography work in imaging tumor angiogenesis (the growth of new blood vessels that tumors need to grow) in patients with inflammatory breast cancer (a type of breast cancer in which the breast looks red and swollen and feels warm) receiving preoperative chemotherapy. Zirconium Zr 89 bevacizumab is a radio tracer. Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance. Radiotracers are used to make images of processes that are happening in the body, but they do not affect how the body works. Zirconium Zr 89 bevacizumab is made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr). 89Zr-bevacizumab is used for an imaging procedure called positron emission tomography/computed tomography (PET/CT). Zirconium Zr 89 bevacizumab PET/CT imaging may be able to measure new blood vessel formations to determine where the cancer is in the body and if cancer is being killed by chemotherapy in patients with inflammatory breast cancer receiving preoperative chemotherapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01894451.
PRIMARY OBJECTIVE:
I. To determine the feasibility of zirconium Zr 89 bevacizumab (89Zr-bevacizumab)-PET/CT imaging in patients with inflammatory breast cancer (IBC).
SECONDARY OBJECTIVES:
I. To determine the safety of 89Zr-bevacizumab-PET/CT imaging in patients with IBC.
II. To confirm the biodistribution and dosimetry estimates for 89Zr-bevacizumab in patients with IBC.
III. To determine if 89Zr-bevacizumab accumulation in primary IBC tumors correlates with the extent of angiogenesis determined by microvessel density, vessel diameter, and vascular pericyte coverage obtained from research biopsy before chemotherapy, after two cycles of chemotherapy, and after chemotherapy from research biopsy or research tissue from mastectomy after chemotherapy if residual disease is present.
IV. To determine if 89Zr-bevacizumab accumulation correlates with tumor vascular endothelial growth factor (VEGF) levels in primary IBC tumors.
V. To correlate the changes in tumor uptake on 89Zr-bevacizumab-PET/CT with standard imaging response using magnetic resonance imaging (MRI) and fluorodeoxyglucose F-18 (FDG)-PET/CT.
EXPLORATORY OBJECTIVES:
I. To compare the ability of 89Zr-bevacizumab-PET/CT to detect primary IBC tumor and distant metastases with standard imaging modalities, i.e., breast MRI and FDG-PET/CT, prior to preoperative therapy.
II. To assess the predictive value of 89Zr-bevacizumab-PET/CT after preoperative chemotherapy for determining pathologic response at definitive mastectomy.
III. To assess the early predictive value of 89Zr-bevacizumab-PET/CT after 2 cycles of preoperative chemotherapy for determining pathologic response at definitive mastectomy.
IV. To compare the amount 89Zr-bevacizumab accumulation in the primary IBC tumor, local and distant metastases.
OUTLINE:
Patients receive 89Zr-bevacizumab intravenously (IV) and 3-4 days later undergo 89Zr-bevacizumab-PET/CT imaging at baseline, after 2 cycles of preoperative chemotherapy (about 3-6 weeks after the start of preoperative chemotherapy), and then within 1-2 weeks following the completion of preoperative chemotherapy (approximately 16-24 weeks after the start of chemotherapy). Patients also undergo FDG PET/CT and MRI imaging after 2 cycles of preoperative chemotherapy and within 1-2 weeks following the completion of preoperative chemotherapy (FDG PET/CT only). Patients achieving an appropriate disease response as determined by the treating physicians, then proceed to modified radical mastectomy, per the standard-of-care. Patients not achieving an adequate response and is deemed not to be a surgical candidate, then undergo a research breast biopsy and additional therapies will be considered per standard-of-care.
After completion of study, patients are followed up for 30 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorHeather Jacene