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

This study has been completed.
Sponsor:
Collaborator:
Roche Farma, S.A
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01338753
First received: March 4, 2011
Last updated: September 9, 2013
Last verified: September 2013

March 4, 2011
September 9, 2013
October 2009
October 2010   (final data collection date for primary outcome measure)
  • Evaluation of SNPs genotyping. [ Time Frame: This evaluation will be performed within 14 days before start of treatment ] [ Designated as safety issue: No ]
    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.
  • 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). ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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. ] [ Designated as safety issue: No ]
    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).
  • Positron emission tomography (PET) scan [ Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment) ] [ Designated as safety issue: No ]
    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
  • Positron emission tomography (PET) scan [ Time Frame: This evaluation will be performed within 12-19 days after first cycle ] [ Designated as safety issue: No ]
    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
  • Positron emission tomography (PET) scan [ Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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
  • Evaluation of Genomic tissular profile in a sample of biopsy [ Time Frame: This evaluation will be performed within 12-19 days after first cycle ] [ Designated as safety issue: No ]
    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
  • Evaluation of Genomic tissular profile in a sample of biopsy [ Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle ] [ Designated as safety issue: No ]
    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).
  • Evaluation of Proteomic expression in blood serum [ Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment) ] [ Designated as safety issue: No ]
    To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
  • Evaluation of Proteomic expression in blood serum [ Time Frame: This evaluation will be performed within 12-19 days after first cycle. Description: ] [ Designated as safety issue: No ]
    To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
  • Evaluation of Proteomic expression in blood serum [ Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle. ] [ Designated as safety issue: No ]
    To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
Same as current
Complete list of historical versions of study NCT01338753 on ClinicalTrials.gov Archive Site
Evaluation of Complete pathological response in surgical piece [ Time Frame: This evaluation will be performed within 20-22 weeks after start of treatment. ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Neoplasms
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.

Other Names:
  • Avastin
  • Taxotere
  • Adriamycin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
May 2011
October 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01338753
ML22197/2009-01, 2009-011037-27
Yes
Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
Roche Farma, S.A
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 Yagüe
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
Clinica Universidad de Navarra, Universidad de Navarra
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP