Study to Evaluate Markers of Response in Locally Advanced Breast Cancer

NCT ID: NCT01338753

Last Updated: 2013-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-05-31

Brief 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

Keywords

breast; cancer; Pharmacogenomics; bevacizumab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Avastin; Taxotere; Adriamycin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Roche Farma, S.A

INDUSTRY

Sponsor Role: collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Anton, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Jesus Garcia-Foncillas, MD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universitaria de Navarra

Alfonso Yubero, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Obispo Polanco

Isabel Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Donosti

Jose Manuel Lopez-Vega, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Marqués de Valdecilla

Blanca Hernando, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Yagüe

Jose Juan Illarramendi, Md

Role: PRINCIPAL_INVESTIGATOR

Hospital de Navarra

Irene Gil, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Tudela

Purificacion Martinez del Prado, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Basurto

Rosa Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario San Millán San Pedro De La Rioja

Arrate Plazaola, MD

Role: PRINCIPAL_INVESTIGATOR

Onkologikoa

Serafin Morales, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Arnau Vilanova de Lleida

Locations

Hospital Obispo Polanco

Teruel, Aragon, Spain

Hospital Miguel Servet

Zaragoza, Aragon, Spain

Hospital General Yagüe

Burgos, Burgos, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital de Donosti

San Sebastián, Guipúzcoa, Spain

Onkologikoa

San Sebastián, Guipúzcoa, Spain

Hospital de San Millan

Logroño, La Rioja, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital de Navarra

Pamplona, Navarre, Spain

Hospital de Tudela

Tudela, Navarre, Spain

Hospital de Basurto

Bilbao, Vizcaya, Spain

Countries

Spain

Other Identifiers

2009-011037-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML22197/2009-01

Identifier Type: -

Identifier Source: org_study_id