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

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.

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.

Inclusion Criteria:

• Female
• Signed Informed consent form
• Ages between 18 and 70
• 12 months of life expectancy at least
• Histologically confirmed breast cancer
• No previous treatment for locally advanced breast cancer
• Her2+ o Her2-
• Disease measurable by PET and/or MRI
• ECOG 0-1
• Adequate organic function
• Negative pregnancy test; fertile women must use anticonceptive methods after ICF and 30 days after last study drug administration
• Enough capability to follow the procedures and follow-up test included in the protocol

Exclusion Criteria:

• Metastatic disease
• Inadequate health to receive the study chemotherapy
• Previous breast cancer treatment
• Pregnant or lactating women
• Major surgery or significative traumatic injure in the 28 days previous to inclusion, or during treatment.
• Minor surgery 24 hours before first bevacizumab infusion
• Concomitant or recent aspirin(>325mg/day)or clopidogrel(>75mg/day) treatment
• Concomitant or recent oral anticoagulant treatment
• History or evidence or bleeding diathesis or hereditary coagulopathy with bleeding risk
• Uncontrolled arterial hypertension
• Clinical significative heart disease, or uncontrolled severe arrhythmia disorder
• Unhealed wounds, peptic ulcer or bone fracture
• History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess, 6 months before inclusion
• Evidence of any other disease, neurological or metabolical disorder or physical examination or laboratory finding related with any disease that makes the subjet ineligible for the study treatment or that put the subject in risk because of the study treatment.
• Psychiatric disorders that may prevent the subject to complete the study treatment
• Current participation in any other trial involving an investigational drug, or participation in any kind of trial 28 days before inclusion
• Chronical corticosteroid treatment
• Hypersensitivity reaction to bevacizumab or any of its components or any of the other study drugs or components
• Patients diagnosed with different neoplasms the previous 5 years excluding non melanoma skin cancer and resected cervical cancer