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

NCT01420146 | Completed Phase 1 Results

• 1 other identifier: IJBMNZrT003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms; Secondary; HER2 Positive Carcinoma of Breast

Outcome Measures

Primary Outcomes (1)

• 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

  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).

  4 years

Secondary Outcomes (2)

• Time Activity Curve

  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

• HER2 Extracellular Domain

  within 60 min before tracer injection

Study Arms (1)

Zr89-trastuzumab PET/CT

EXPERIMENTAL

Zr89-trastuzumab PET/CT single arm

Drug: Zr89-trastuzumab

Interventions

Zr89-trastuzumab DRUG

trastuzumab labelled with zirconium 89 for PET/CT

Also known as: HER2 ImmunoPET/CT, HER2 receptor imaging, Breast cancer molecular imaging

Zr89-trastuzumab PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• Patients with FDG-PET positive metastatic lesions.
• Brain metastases are allowed provided they are controlled and they are not the sole site of metastatic disease.
• Patient planned to have metastatic site biopsy for HER2 status control.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1
• For women of childbearing potential a pregnancy test will be done and an agreement to use a highly-effective non hormonal form of contraception.
• Agreement from the patient to participate in this imaging study and if indicated agreement to biopsy one or two accessible lesions.
• Signed written informed consent (approved by the Ethics Committee) obtained prior to any study procedure

You may not qualify if:

• Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
• Pregnant or lactating women
• Current known infection with HIV, HBV, or HCV
• Known severe hypersensitivity to trastuzumab
• Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• Patients with bone only metastases are not eligible
• Psychiatric illness/social situations that would limit compliance with study requirements
• Patients who received lapatinib within the 7 days prior to HER immunoPET/CT.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Jules Bordet Institut

Brussels, Brussels Capital, 1000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Géraldine Gebhart
• Organization: Institut Jules Bordet

geraldine.gebhart@bordet.be

025413095

Study Officials

• Patrick Flamen, MD, PhD

  Jules Bordet Institut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 19, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 18, 2017
• Results First Posted: April 18, 2017

Record last verified: 2015-01

Locations

BE (1)