NCT03827317

Brief Summary

This mechanistic study will be the first study to assess the efficacy of \[18F\]GE-226 to target HER2 expression in patients with metastatic breast cancer. The study will establish the pharmacokinetics of \[18F\]GE-226 and the optimum time-point for performing static scans in this patient population.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
7mo left

Started Mar 2019

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Mar 2019Dec 2026

First Submitted

Initial submission to the registry

January 17, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 8, 2019

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

7.1 years

First QC Date

January 17, 2019

Last Update Submit

August 23, 2024

Conditions

Breast Cancer

Keywords

HER2imagingPETpositron emission tomography

Outcome Measures

Primary Outcomes (2)

  • Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using semi-quantitative parameters

    Tumoral uptake of \[18F\]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using SUV and AUC.

    24 months

  • Tumoral uptake of [18F]GE-226 in patients with breast cancer measured using fully quantitative parameters

    Tumoral uptake of \[18F\]GE-226 in patients with HER2 positive and HER2 negative breast cancer measured using Ki in the case or irreversible uptake, and binding potential in the case of reversible uptake.

    24 months

Secondary Outcomes (6)

  • Adverse events of [18F]GE-226 injection

    0 hour, 48 hours

  • Serum biochemistry change from baseline measurement

    0 hour, 48 hours

  • Haematology change from baseline measurement

    0 hour, 48 hours

  • Immunology change from baseline measurement

    0 hour, 48 hours

  • Urine change from baseline measurement

    0 hour, 48 hours

  • +1 more secondary outcomes

Study Arms (2)

HER2 positive metastatic breast cancer

OTHER

8 HER2 positive patients (determined using the most recent biopsy) will be recruited. Dynamic \[18F\]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of \[18F\]GE-226 and hence determine the optimal imaging time point for \[18F\]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours.

Radiation: [18F]GE-226

HER2 negative metastatic breast cancer

OTHER

8 HER2 negative patients (determined using the most recent biopsy) will be recruited. Dynamic \[18F\]GE-226 PET imaging over 90 minutes, radial artery sampling will be performed to establish the pharmacokinetic profile of \[18F\]GE-226 and hence determine the optimal imaging time point for \[18F\]GE-226 PET scans. Tumour uptake in individual metastases (and the target lesion) will be reported. Uptake will be compared between HER2 positive and negative tumours.

Radiation: [18F]GE-226

Interventions

[18F]GE-226RADIATION

\[18F\]GE-226 is a radiolabelled Affibody® tracer which binds to the HER2 receptor with high affinity at a different epitope than trastuzumab. The active molecule is a 61 amino acid peptide that is modified site-specifically with one fluorobenzaldehyde molecule at the C-terminal.

HER2 negative metastatic breast cancerHER2 positive metastatic breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative).
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with a histological diagnosis of breast cancer with known HER2 status ((8 positive and 8 negative).
  • Written informed consent prior to admission in the study.
  • Target lesion diameter of ≥15mm that has not been previously irradiated.
  • Female patients aged ≥ 18 years of age.
  • For all patients: histologically confirmed locally advanced/metastatic breast cancer with a biopsy within the last 12 months confirming HER2 status by either immunohistochemistry (IHC), Silver In Situ Hybridization (SISH) or Fluorescent In Situ Hybridization (FISH).
  • ECOG performance status 0-2
  • Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of \[18F\]GE-226
  • Life expectancy \> 3 months
  • Adequate organ function as defined by
  • Hb≥10g/L
  • WBC≥3.0 x 109/L
  • PLT≥80 x 109/L
  • Serum creatinine ≤1.4mg/dl
  • SGOT and SGPT ≤2 x ULN
  • Total bilirubin ≤ 2 x ULN or 3.0 mg/dl in patients with Gilbert's syndrome
  • +1 more criteria

You may not qualify if:

  • Pregnant or lactating women.
  • History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis).
  • Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.
  • Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg)).
  • Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent.
  • Patients classified as radiation workers
  • Patients on therapeutic doses of anticoagulants, or with a raised prothrombin time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Laura M Kenny, MD FRCP PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HERPET Trial Coordinator

CONTACT

0207 59 42804herpet@imperial.ac.uk; g.gopalakrishnan@imperial.ac.uk

Gosala Gopalakrishnan, PhD

CONTACT

0207 59 42804g.gopalakrishnan@imperial.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Non-randomised cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

February 1, 2019

Study Start

March 8, 2019

Primary Completion

March 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)