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Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients (IJBMNZrT003)

This study is currently recruiting participants.
Verified March 2013 by Jules Bordet Institute
Sponsor:
Information provided by (Responsible Party):
Jules Bordet Institute
ClinicalTrials.gov Identifier:
NCT01420146
First received: August 8, 2011
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.


Condition Intervention Phase
Breast Neoplasms
Secondary
HER2 Positive Carcinoma of Breast
 Drug: Zr89-trastuzumab
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Jules Bordet Institute:

Primary Outcome Measures:
  • Test the diagnostic accuracy of the HER2 imaging using the labelled monoclonal antibody trastuzumab by correlating the HER2 PET/CT imaging with the FDG-PET/CT and molecular characterization of tumor samples with discordant image findings [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time activity curve [ Time Frame: blood sample at 5, 15, 30, 60 minutes, 1 day, 2 days and 4 or 6 days after tracer injection. Images : Day 0, Day 2 and Day 4 or 6 ] [ Designated as safety issue: No ]
    Time activity curve of normal organ and tumor lesions: pharmacokinetic

  • HER2 Extracellular domain [ Time Frame: within 60 min before tracer injection ] [ Designated as safety issue: No ]
    evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zr89-trastuzumab PET/CT
Zr89-trastuzumab PET/CT single arm
 Drug: Zr89-trastuzumab
trastuzumab labelled with zirconium 89 for PET/CT
Other Names:
  • HER2 ImmunoPET/CT
  • HER2 receptor imaging
  • Breast cancer molecular imaging

Detailed Description:

This is the first belgian feasibility study of HER2 imaging using a labelled monoclonal antibody, namely trastuzumab labelled with zirconium 89.

The aims of this study are:

I/ Evaluate the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab (based on the Groningen experience), through the analysis of the correlation between the FDG-PET/CT and the HER2 immunoPET.

II/ PET quantification of HER2 receptor by using the images and the blood pharmacokinetic of the tracer.

III/ In the subset of patients for whom biopsies of metastatic sites have not been carried out previously and are of an easy access, tissue will be acquired as part of the validation of the HER2 immunoPET and as an attempt to better understand the molecular heterogeneity of HER2 positive breast cancer at the time of relapse.

IV/Evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. All patients selected for this imaging study are patients scheduled to start trastuzumab-based therapy for advanced HER2 positive breast cancer (This includes trastuzumab alone, trastuzumab + chemotherapy, trastuzumab + endocrine therapy).
  2. Histologically confirmed HER 2 positive (defined as FISH amplification ratio more than 2.2) invasive carcinoma of the breast (primary tumor at diagnosis) with locally recurrent or metastatic disease.
  3. Patients with FDG-PET positive metastatic lesions.
  4. Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
  5. Patient planned to have metastatic site biopsy for HER2 status control.
  6. Age ≥ 18 years
  7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
  8. For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
  9. Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
  10. Signed written informed consent (approved by the Ethics Committee) obtained prior to any study procedure

Exclusion criteria:

  1. Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
  2. Pregnant or lactating women
  3. Current known infection with HIV, HBV, or HCV
  4. Known severe hypersensitivity to trastuzumab
  5. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
  6. Patients with bone only metastases are not eligible
  7. Psychiatric illness/social situations that would limit compliance with study requirements
  8. Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420146

Contacts
Contact: Geraldine Gebhart, MD 003225417314 geraldine.gebhart@bordet.be
Contact: Julie Gaye, Ir 003225413207 julie.gaye@bordet.be

Locations
Belgium
Jules Bordet Institut Recruiting
Brussels, Belgium, 1000
Contact: Geraldine Gebhart, MD     003225417314     geraldine.gebhart@bordet.be    
Contact: Julie Gaye, Ir     003225413207     julie.gaye@bordet.be    
Sponsors and Collaborators
Jules Bordet Institute
Investigators
Principal Investigator: Patrick Flamen, MD, PhD Jules Bordet Institut
  More Information

No publications provided

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01420146     History of Changes
Other Study ID Numbers: IJBMNZrT003
Study First Received: August 8, 2011
Last Updated: March 14, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Carcinoma
Neoplasms by Site
Breast Diseases
Skin Diseases
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013