HER2-PET Imaging Using 89Zr-trastuzumab in Low HER2-expressing (HER2-low) Breast Cancers

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

A strategy to target the oncogenic receptor HER2 using a version of the anti-HER2 therapeutic antibody trastuzumab coupled to desferrioxamine (DFO) and radiolabeled with zirconium-89 (\[89Zr\]-DFO-trastuzumab) has been successfully evaluated in our group in preclinical settings. Clinical studies by other groups in recent years have shown the potential of targeting HER2+ lesions with \[89Zr\]-DFO-trastuzumab in patients with HER2+ cancers. We now want to establish the diagnostic potential of a protocol adding \[89Zr\]-DFO-trastuzumab PET imaging to FDG PET already used in the clinic for the detection of HER2-expressing cancers, including low expression levels considered until now as HER2-negative (HER2-low, IHC score 1+ and 2+ without FISH amplification of the HER2 locus). The HER2-low status has recently gained relevance thanks to large studies showing the efficacy of immunotherapy combined with drugs such as Enhertu (trastuzumab-deruxtecan), while trastuzumab alone was traditionally only effective for HER2+ cancers (IHC score 2+/FISH+, or 3+). In particular, we aim to develop a method to assess whole-body intertumoral heterogeneity in HER2 expression in order to detect cases with heterogeneous diseases and thus better stage patients and guide the optimal choice of personalized and targeted treatment to use. More specifically, the project aims to image with \[89Zr\]-DFO-trastuzumab PET patients with cancer, particularly breast cancer, but also esophageal, gastric, ovarian, endometrial and lung cancer, and whose primary tumor status is HER2-low.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• HER2-low metastatic breast cancer;

• At least 18 years-old ;

• Able to stay in supine position for at least 30 minutes;

• Written inform consent.

Locations
Other Locations
Canada
Centre de recherche du CHUS
RECRUITING
Sherbrooke
Contact Information
Primary
Michel Paquette, PhD
michel.paquette@usherbrooke.ca
819-346-1110
Backup
Esteban Espinosa-Bentancourt
Esteban.Espinosa-Bentancourt@USherbrooke.ca
819-346-1110
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 40
Treatments
Experimental: 89Zr-trastuzumab PET/CT imaging of HER2-low patients
Following their inform consent, HER2-low breast cancer patients will be invited to come to our research center twice. The first time patients will receive an intravenous dose of 10-50mg trastuzumab, followed by a 0.5 MBq/kg (max 60 MBq) dose of 89Zr-trastuzumab. Patients will come back for a second visit 3-6 days later to get their PET/CT imaging examination. Images will be evaluated by two PET-trained physicians, and analysed by an imaging scientist.
Related Therapeutic Areas
Sponsors
Leads: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators: Université de Sherbrooke

This content was sourced from clinicaltrials.gov