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

NCT ID: NCT01420146

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2015-09-30

Brief Summary

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

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

Conditions

Breast Neoplasms; Secondary; HER2 Positive Carcinoma of Breast

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Zr89-trastuzumab PET/CT

Zr89-trastuzumab PET/CT single arm

Group Type: EXPERIMENTAL

Zr89-trastuzumab

Intervention Type: DRUG

trastuzumab labelled with zirconium 89 for PET/CT

Interventions

Zr89-trastuzumab

trastuzumab labelled with zirconium 89 for PET/CT

Intervention Type: DRUG

Other Intervention Names

HER2 ImmunoPET/CT; HER2 receptor imaging; Breast cancer molecular imaging

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Flamen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institut

Locations

Jules Bordet Institut

Brussels, Brussels Capital, Belgium

Countries

Belgium

Other Identifiers

IJBMNZrT003

Identifier Type: -

Identifier Source: org_study_id