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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01420146
First Posted: August 19, 2011
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jules Bordet Institute
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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: 4 years ]
    A visual 'patient-based' classification capturing the whole disease burden was developed by using a side-by-side display, comparing baseline FDG-PET/CT(showing all FDG-positive mets independent of their HER2-imaging status) & day4 HER2-PET/CT. Pts were grouped into 4 HER2-PET/CT patterns according to the proportion of FDG avid tumour load showing relevant 89Zr-T uptake. Pattern A: entire tumor load showed pertinent tracer uptake; B: dominant part of tumour load showed tracer uptake; C: minor part of tumor load showed tracer uptake; D: entire tumor load lacked tracer uptake. Patterns A+B='HER2-positive' & C+D='HER2-negative'. In the 20 pts: 4 pts were classified "A", 5"B", 1"C" & 10"D". This classification indicates substantial heterogeneity of 89Zr-T uptake within this so called 'HER2-positive' pt population. After dichotomization, 11(55%) pts were considered as HER2-PET/CT negative. Furthermore, HER2-PET/CT revealed intrapatient heterogeneity of tumour uptake(pts classified B or C).


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 ]
    Time activity curve of normal organ and tumor lesions: pharmacokinetic

  • HER2 Extracellular Domain [ Time Frame: within 60 min before tracer injection ]
    evaluate the concentration of circulating HER2 extracellular domain in the blood and study his possible role as on imaging quality


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420146


Locations
Belgium
Jules Bordet Institut
Brussels, Belgium, 1000
Sponsors and Collaborators
Jules Bordet Institute
Investigators
Principal Investigator: Patrick Flamen, MD, PhD Jules Bordet Institut
  More Information

Responsible Party: Jules Bordet Institute
ClinicalTrials.gov Identifier: NCT01420146     History of Changes
Other Study ID Numbers: IJBMNZrT003
First Submitted: August 8, 2011
First Posted: August 19, 2011
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: January 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents