NCT01985841

Bevacizumab in Combination With Chemotherapy in the Neo-adjuvant Setting for HER2 (-) Breast Cancer

Phase II, Open-label Non-randomized Trial to Investigate the Efficacy of Bevacizumab in Combination With Dose Dense Sequential Chemotherapy in the Neo-adjuvant Setting for HER2 Negative Breast Cancer Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumb	Avastin
DRUG	5-Fluorouracil	5-FU
DRUG	Epirubicin	Farmorubicin
DRUG	Cyclophosphamide	Endoxan
DRUG	Docetaxel	Taxotere

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2013-11-15
• Last updated: 2015-10-08

Locations

6 sites across 1 country: Greece