Study of changes in cancer tissue induced by treatment with bevacizumab in metastatic breast cancer

Phase 2

Recruiting

• Conditions: metastatic breast cancer; Cancer - Breast

• Registration Number: ACTRN12609000904279
• Lead Sponsor: Georgios Kesisis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

histologically proven metastatic breast cancer, locally accessible disease (breast tumor, skin mets, lymph node mets), Performance status (PS) 0-1, normal liver and kidney function

Exclusion Criteria

history of thrombotic disease, uncontrolled brain metastases, pregnancy, lactation, prior bevacizumab exposure, recent surgery (within 4 weeks), active bleeding, active infection, unhealed wound, use of anticoagulants in therapeutic doses

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in the expression of certain genes induced by a single dose of bevacizumab. Changes in gene expression will be assessed with the use of superarray technology (commercially available through Bioscience Corporation). Genes of interest are the Notch pathway and angiogenesis pathway (sets of genes available commercially through Bioscience Corporation)[14 days]

Secondary Outcome Measures

Name	Time	Method
changes of plasma levels of certain angiogenic markers vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (sVEGFR), angiopoietins, basic fibroblast growth factor (bFGF), Tie-1/2, angiostatin, circulating endothelial cells (CEC)[14 days]