NCT00203372

Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)

A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patients With Stage II or Stage III Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Translational Oncology Research International · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and investigate whether changes in gene expression, or the expression of specific biomarkers, are either predictive of response to bevacizumab or indicative of response.

Detailed description

The study combines bevacizumab with a very efficacious combination chemotherapy regimen for the treatment of stage II or stage III primary breast cancer. Safety of the TAC-bevacizumab combination will be evaluated. In addition, the study design incorporates an initial cycle of bevacizumab or placebo alone. Assessing the isolated effects of bevacizumab in a setting where pre- and post-treatment tissue specimens can be obtained will provide essential information about the mechanisms by which VEGF inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of bevacizumab on breast tumor tissue.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab 7.5 and TAC	Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).
DRUG	Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)	placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC
DRUG	Bevacizumab 15 and TAC	one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.
DRUG	Placebo 15 and TAC	one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.

Timeline

• Start date: 2005-05-01
• Primary completion: 2012-06-01
• First posted: 2005-09-20
• Last updated: 2015-10-12

Locations

9 sites across 3 countries: United States, Canada, Ireland