NCT06732336RecruitingPhase 1/2
HER2-PET Imaging in HER2-low Breast Cancers
HER2-PET Imaging Using 89Zr-trastuzumab in Low HER2-expressing (HER2-low) Breast Cancers
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Diseases
- Metastatic breast cancer
- NCT number
- NCT06732336
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 40
- From 1 Dec 2024 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pregnancy or concomitant breast feeding;
Other illness
- Hepatic disorders such as cirrhosis, hepatitis, or any other liver condition judged as significant by the treating physician and that could impair the biliary excretion of 89Zr-trastuzumab;
- Renal disorders considered significant by the treating physician and that could impair the normal elimination of 89Zr-trastuzumab;
- Known hypersensitivity or allergy to trastuzumab, desferrioxamine, or any constituents of 89Zr-trastuzumab.
Who the study is looking for
- HER2-low metastatic breast cancer;
- At least 18 years-old ;
- Able to stay in supine position for at least 30 minutes;
- Written inform consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de recherche du CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.