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Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results

Phase 1
18 Years
Open (Enrolling)
Breast Neoplasms, Secondary, HER2 Positive Carcinoma of Breast

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Trial Information

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients : Correlation With FDG-PET/CT and Anatomopathological Results

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

Inclusion 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

8. Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Patrick Flamen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jules Bordet Institut


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

August 2011

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • Secondary
  • HER2 Positive Carcinoma of Breast
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma