NCT01338753

Study to Evaluate Markers of Response in Locally Advanced Breast Cancer

A Multicenter Phase II Study, to Evaluate the Predictive Markers of Response in Locally Advanced Breast Cancer, Treated With Bevacizumab Combined With Neoadjuvant Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the association between image and certain molecular markers with complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.

Detailed description

This is a pharmacogenomic phase II, multicenter, prospective clinical trial whose main objective is to evaluate the association of molecular and imaging markers with the response to bevacizumab administration in combination with docetaxel and doxorubicin as neoadjuvant chemotherapy in patients diagnose with locally advanced breast cancer.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
OTHER	Bevacizumab, docetaxel and doxorubicin followed by surgery	The dosage form is Parenteral Injection (I/V) for all study drugs. Bevacizumab 15mg/kg in a single dose on day 1. Then 3 weeks later begin the cycles. On the day 1 of the cycle the patient receives Bevacizumab 15mg/kg, docetaxel 60mg/m2 and doxorubicin 50mg/m2. The cycles have a frequency of one every three weeks, and the protocol defines 4 cycles in total. The surgical procedure will be done 4-6 weeks after completion of chemotherapy.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-10-01
• Completion: 2011-05-01
• First posted: 2011-04-19
• Last updated: 2013-09-10

Locations

11 sites across 1 country: Spain