Study to Evaluate Markers of Response in Locally Advanced Breast Cancer (IMAGING)

September 9, 2013 updated by: Clinica Universidad de Navarra, Universidad de Navarra

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Burgos, Spain, 09005
        • Hospital General Yague
    • Aragón
      • Teruel, Aragón, Spain, 44002
        • Hospital Obispo Polanco
      • Zaragoza, Aragón, Spain, 50009
        • Hospital Miguel Servet
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Guipúzcoa
      • San Sebastián, Guipúzcoa, Spain, 20014
        • Hospital de Donosti
      • San Sebastián, Guipúzcoa, Spain, 20014
        • Onkologikoa
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
        • Hospital de San Millan
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universitaria de Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital de Navarra
      • Tudela, Navarra, Spain, 31500
        • Hospital de Tudela
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of SNPs genotyping.
Time Frame: This evaluation will be performed within 14 days before start of treatment
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.
This evaluation will be performed within 14 days before start of treatment
Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI)
Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment).
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).
This evaluation will be performed within 14 days before start of treatment (baseline assesment).
Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI)
Time Frame: This evaluation will be performed within 12-19 days after first cycle
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).
This evaluation will be performed within 12-19 days after first cycle
Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI)
Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle.
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).
This evaluation will be performed within 12-19 days aftet fifth cycle.
Positron emission tomography (PET) scan
Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment)
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
This evaluation will be performed within 14 days before start of treatment (baseline assesment)
Positron emission tomography (PET) scan
Time Frame: This evaluation will be performed within 12-19 days after first cycle
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
This evaluation will be performed within 12-19 days after first cycle
Positron emission tomography (PET) scan
Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle
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
This evaluation will be performed within 12-19 days aftet fifth cycle
Evaluation of Genomic tissular profile in a sample of biopsy
Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment
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
This evaluation will be performed within 14 days before start of treatment (baseline assesment
Evaluation of Genomic tissular profile in a sample of biopsy
Time Frame: This evaluation will be performed within 12-19 days after first cycle
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
This evaluation will be performed within 12-19 days after first cycle
Evaluation of Genomic tissular profile in a sample of biopsy
Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle
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).
This evaluation will be performed within 12-19 days aftet fifth cycle
Evaluation of Proteomic expression in blood serum
Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment)
To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
This evaluation will be performed within 14 days before start of treatment (baseline assesment)
Evaluation of Proteomic expression in blood serum
Time Frame: This evaluation will be performed within 12-19 days after first cycle. Description:
To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
This evaluation will be performed within 12-19 days after first cycle. Description:
Evaluation of Proteomic expression in blood serum
Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle.
To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
This evaluation will be performed within 12-19 days aftet fifth cycle.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of Complete pathological response in surgical piece
Time Frame: This evaluation will be performed within 20-22 weeks after start of treatment.
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.
This evaluation will be performed within 20-22 weeks after start of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Farma, S.A

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Anton, MD, Hospital Miguel Servet
  • Principal Investigator: Jesus Garcia-Foncillas, MD, Clinica Universitaria de Navarra
  • Principal Investigator: Alfonso Yubero, MD, Hospital Obispo Polanco
  • Principal Investigator: Isabel Alvarez, MD, Hospital Donosti
  • Principal Investigator: Jose Manuel Lopez-Vega, MD, Hospital Universitario Marqués de Valdecilla
  • Principal Investigator: Blanca Hernando, MD, Hospital General Yague
  • Principal Investigator: Jose Juan Illarramendi, Md, Hospital de Navarra
  • Principal Investigator: Irene Gil, MD, Hospital de Tudela
  • Principal Investigator: Purificacion Martinez del Prado, MD, Hospital de Basurto
  • Principal Investigator: Rosa Sanchez, MD, Complejo Hospitalario San Millán San Pedro De La Rioja
  • Principal Investigator: Arrate Plazaola, MD, Onkologikoa
  • Principal Investigator: Serafin Morales, MD, Hospital Universitario Arnau Vilanova de Lleida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML22197/2009-01
  • 2009-011037-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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