Imaging for Response Assessment of Neoadjuvant Chemotherapy in Primary Breast Cancer (GALADON)
Status:
Terminated
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
The GALADON trial is a diagnostic and interventional study in which different molecular
imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance
Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods
(mammography, ultrasound) to see if there can detect an early response to a combined
neoadjuvant therapy with bevacizumab and docetaxel in patients with locally advanced breast
cancer. Neoadjuvant chemotherapy (this means patients were treated before the tumor was
removed by surgery) with a drug like trastuzumab (monoclonal antibody) which is target to the
Her2-protein is much more powerful than with chemotherapy alone because it is normalizing the
blood supply and improves tumor delivery of conventional chemotherapy like docetaxel. The
HER2 protein is only available in about 30 % of breast cancer types. bevacizumab is another
humanized monoclonal antibody like trastuzumab but is effective not only in patients with an
positive HER2 status and in combination with trastuzumab it may emphasize the effect in
reduction of tumor growth. Bevacizumab is approved in advanced disease, but no major
neoadjuvant data available so far for primary breast cancer. As the therapy with monoclonal
antibody regimes are expensive and may cause severe side effects predictive factors to select
patients who will benefit from such highly specific drugs before therapy start would be
medically and economically highly valuable. In this study the efficacy of combined
neoadjuvant chemotherapy with bevacizumab, trastuzumab and docetaxel in Arm A and bevacizumab
and docetaxel in Arm B should be evaluated and the predictive impact of different imaging
methods for tumor response should be shown.