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Study to Evaluate Markers of Response in Locally Advanced Breast Cancer

NCT01338753 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2013-09-10

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Roche Farma, S.A

    collaborator INDUSTRY

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Antonio Anton, MD · Hospital Miguel Servet

  • Jesus Garcia-Foncillas, MD · Clinica Universitaria de Navarra

  • Alfonso Yubero, MD · Hospital Obispo Polanco

  • Isabel Alvarez, MD · Hospital Donosti

  • Jose Manuel Lopez-Vega, MD · Hospital Universitario Marqués de Valdecilla

  • Blanca Hernando, MD · Hospital General Yagüe

  • Jose Juan Illarramendi, Md · Hospital de Navarra

  • Irene Gil, MD · Hospital de Tudela

  • Purificacion Martinez del Prado, MD · Hospital de Basurto

  • Rosa Sanchez, MD · Complejo Hospitalario San Millán San Pedro De La Rioja

  • Arrate Plazaola, MD · Onkologikoa

  • Serafin Morales, MD · Hospital Universitario Arnau Vilanova de Lleida

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-10-31
Completion
2011-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338753 on ClinicalTrials.gov