Investigators propose to study the efficacy of Bevacizumab plus systemic chemotherapy prior to surgery in order to make a locally advanced tumor operable. Treatment is thus expected to induce a maximum tumor shrinkage within a short period (usually 3-6 months). In addition Bevacizumab (Avastin) is to be administered as early as possible during the disease stages. The primary aim of this study is to evaluate the preliminary antitumor activity in terms of pathological complete responses (pCR) of bevacizumab in combination with chemotherapy.
The aim of administering systemic therapy prior to surgery is to make a locally advanced tumor operable or to allow conservative surgery in the case of a T2-T3 tumor. Therefore, treatment is expected to induce a maximum tumor shrinkage within a short period. In addition and based on the anti-angiogenic MoA, bevacizumab (Avastin) is to be administered as early as possible during the disease stages. Bevacizumab has already been tested in the neoadjuvant setting with encouraging results. In a first trial patients with inoperable locally advanced breast cancer received docetaxel with or without bevacizumab with five clinical Complete Responses and 24 Partial Responses. In a second trial there was also reported the results of the combination of bevacizumab with doxorubicin and docetaxel for the treatment of inflammatory breast cancer. Then, a set of studies of primary therapy exploring the activity of different regimens have confirmed the role of baseline pathological features of the tumor in predicting the responsiveness to primary therapy. A 22% pathological complete responses (pCR) rate has been achieved in a study combining bevacizumab together with Xeloda and Taxotere suggesting that bevacizumab addition to chemotherapy in the neoadjuvant treatment is feasible showing promising activity while no unexpected toxicities were reported. Thus, a very high interest exists from our clinicians mostly within our cooperative groups which cover the largest national oncology centers to be involved and run such a study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
"IASO" General Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece
Heraklion, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
Number of Patients with Complete Response
Patients will be assessed for tumor response on week 8 and on week 16. Patients with tumor reduction will proceed on surgery. Histology report will confirm the complete or partial responses to chemotherapy.
Time frame: On week 8 and 16
Overall Survival
Patients overall survival will be calculated from the date of the first chemotherapy cycle until the date of death from any cause
Time frame: 3 years
Progression Free Survival
Patients will be assessed every 8 weeks, from date of randomization until the end of treatment and then every 3 months until the date of first documented disease progression or date of death from any cause, whichever came first, up to 260 weeks (65 months).
Time frame: 5 years
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NONE
Enrollment
34
Endoxan
Taxotere
"Euromedica" Hospital of Thessaloniki
Thessaloniki, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece