NCT06732336 HER2-PET Imaging in HER2-low Breast Cancers
| NCT ID | NCT06732336 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke |
| Condition | Breast Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2024-12-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * HER2-low metastatic breast cancer; * At least 18 years-old ; * Able to stay in supine position for at least 30 minutes; * Written inform consent. Exclusion Criteria: * Pregnancy or concomitant breast feeding; * 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.
Contact & Investigator
Éric E Turcotte, MD, FRCPC
PRINCIPAL INVESTIGATOR
Université de Sherbrooke
Frequently Asked Questions
Who can join the NCT06732336 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06732336 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06732336 currently recruiting?
Yes, NCT06732336 is actively recruiting participants. Contact the research team at michel.paquette@usherbrooke.ca for enrollment information.
Where is the NCT06732336 trial being conducted?
This trial is being conducted at Sherbrooke, Canada.
Who is sponsoring the NCT06732336 clinical trial?
NCT06732336 is sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke. The principal investigator is Éric E Turcotte, MD, FRCPC at Université de Sherbrooke. The trial plans to enroll 40 participants.
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