Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Docetaxel

Bevacizumab

Doxorubicin

Liposomal doxorubicin

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

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.

Bevacizumab, docetaxel and doxorubicin followed by surgery

Antonio Anton, MD

Jesus Garcia-Foncillas, MD

Alfonso Yubero, MD

Isabel Alvarez, MD

Jose Manuel Lopez-Vega, MD

Blanca Hernando, MD

Jose Juan Illarramendi, Md

Irene Gil, MD

Purificacion Martinez del Prado, MD

Rosa Sanchez, MD

Arrate Plazaola, MD

Serafin Morales, MD

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.

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 analysis of genetic differences will be determined through analysis of single nucleotide polymorphisms. It will be assesed before starting the treatment using Affymetrix's Human Mapping 500k array set.

The radiological interpretation of the images will evaluate size, shape, extent, distribution and kinetics of the lesons according to American College of Radiology Breast Imaging Reporting and Data System (ACR BIRADS- MRI (2003) guidelines).

It will be determined the association between tissue:blood activity ratio and hypoxic tumor volume by 18F-fluoromisonidazole positron emission tomography (FMISO-PET). DNA synthesis, assesed by \[18F\]-fluoro-3'-deoxy-3'-L-fluorothymidine PET (FLT-PET), will be compared to quantitative kinetics data adquired through previously described DCE-MRI. Finally, these results will be correlated with the Risk Score obtained in the genomic analysis

A correlative analysis will be performed between the expression profile of the sample obtained by Affymetrix 's GeneChip Human Genome U133 and its association with tumor response (based on the imaging markers described previously) on the proposed stages (baseline, before first cycle of treatment and after fifth cycle of treatment

A correlative analysis will be performed between the expression profile of the sample obtained by Affymetrix 's GeneChip Human Genome U133 and its association with tumor response (based on the imaging markers described previously) on the proposed stages (baseline, before first cycle of treatment and after fifth cycle of treatment).

To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.

To determine if a patient has undergone complete pathological response, an anatomo-pathological study will be conducted on the surgical piece. The evaluation will follow the Miller and Payne criteria; a complete response will be considered just in the absence of invasive tumor cells in breast and lymphatic nodules.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Evaluate Markers of Response in Locally Advanced Breast Cancer	NCT01338753	Breast Neoplasm...	Bevacizumab, do...	18 Years - 70 Years	Clinica Universidad de Navarra, Universidad de Navarra
Study to Evaluate Markers of Response in Locally Advanced Breast Cancer	NCT01338753	Breast Neoplasm...	Bevacizumab, do...	18 Years - 70 Years	Clinica Universidad de Navarra, Universidad de Navarra

Spots Global Cancer Trial Database for bevacizumab, docetaxel and doxorubicin followed by surgery