40 Participants Needed

HER2-PET Imaging for Breast Cancer

MP
EE
Overseen ByEsteban Espinosa-Bentancourt
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug 89Zr-trastuzumab for HER2-PET imaging in breast cancer?

Research shows that 89Zr-trastuzumab PET imaging can help identify HER2-positive breast cancer lesions, even in cases where standard methods struggle to determine HER2 status. This imaging technique can also predict how well patients respond to pre-surgery treatments, potentially reducing the need for surgery.12345

Is 89Zr-trastuzumab safe for use in humans?

Studies have shown that 89Zr-trastuzumab is generally safe for use in humans, with no toxicities reported in trials involving patients with HER2-positive breast cancer.35678

How is HER2-PET Imaging for Breast Cancer different from other treatments?

HER2-PET Imaging for Breast Cancer is unique because it uses a special imaging technique with a tracer called 89Zr-trastuzumab to detect HER2-positive cancer cells, even when standard tests can't determine HER2 status. This approach helps in making more informed treatment decisions and can identify HER2-positive metastases in patients who initially had HER2-negative breast cancer.23459

What is the purpose of this trial?

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.

Research Team

ÉE

Éric E Turcotte, MD, FRCPC

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

Inclusion Criteria

My breast cancer is HER2-low and has spread.
Written informed consent
I can lie on my back for at least 30 minutes without discomfort.

Exclusion Criteria

Known hypersensitivity or allergy to trastuzumab, desferrioxamine, or any constituents of 89Zr-trastuzumab
I do not have significant liver conditions that could affect drug processing.
Pregnancy or concomitant breastfeeding
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intravenous dose of trastuzumab followed by 89Zr-trastuzumab, with PET/CT imaging conducted 3-6 days later

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

  • 89Zr-trastuzumab
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 89Zr-trastuzumab PET/CT imaging of HER2-low patientsExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Lead Sponsor

Trials
64
Recruited
33,600+

Université de Sherbrooke

Collaborator

Trials
317
Recruited
79,300+

Findings from Research

The study involving 14 patients with HER2-positive metastatic breast cancer found that administering 50 mg of (89)Zr-trastuzumab to trastuzumab-naive patients and 10 mg to those already on trastuzumab was optimal for PET imaging, with the best assessment occurring 4-5 days post-injection.
(89)Zr-trastuzumab effectively allowed for the visualization and quantification of HER2-positive lesions, revealing both known and previously undetected tumors, indicating its potential utility in improving cancer diagnosis and treatment monitoring.
Biodistribution of 89Zr-trastuzumab and PET imaging of HER2-positive lesions in patients with metastatic breast cancer.Dijkers, EC., Oude Munnink, TH., Kosterink, JG., et al.[2022]
The study explored the use of 89Zr-trastuzumab PET/CT imaging for evaluating the response to neoadjuvant systemic therapy in HER2-positive breast cancer patients, finding it feasible for identifying primary tumors and metastatic lymph nodes.
While qualitative assessment of PET/CT did not outperform standard MRI, the quantitative measures showed promise for more accurately evaluating treatment response, particularly in distinguishing between complete and partial responses.
89Zr-Trastuzumab PET/CT Imaging of HER2-Positive Breast Cancer for Predicting Pathological Complete Response after Neoadjuvant Systemic Therapy: A Feasibility Study.Linders, DGJ., Deken, MM., van Dam, MA., et al.[2023]
Imaging with Zr-trastuzumab PET/CT can successfully identify unsuspected HER2-positive metastases in some patients with HER2-negative primary breast cancer, as demonstrated in a study of 11 patients where 1 out of 4 suspicious lesions was confirmed HER2-positive.
However, the study also revealed a challenge with false-positive results, as 3 out of 4 suspicious lesions were found to be HER2-negative, indicating that while Zr-trastuzumab PET/CT is promising, its specificity needs to be improved.
89Zr-Trastuzumab PET/CT for Detection of Human Epidermal Growth Factor Receptor 2-Positive Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer.Ulaner, GA., Hyman, DM., Lyashchenko, SK., et al.[2018]

References

Biodistribution of 89Zr-trastuzumab and PET imaging of HER2-positive lesions in patients with metastatic breast cancer. [2022]
89Zr-Trastuzumab PET/CT Imaging of HER2-Positive Breast Cancer for Predicting Pathological Complete Response after Neoadjuvant Systemic Therapy: A Feasibility Study. [2023]
89Zr-Trastuzumab PET/CT for Detection of Human Epidermal Growth Factor Receptor 2-Positive Metastases in Patients With Human Epidermal Growth Factor Receptor 2-Negative Primary Breast Cancer. [2018]
89Zr-trastuzumab PET supports clinical decision making in breast cancer patients, when HER2 status cannot be determined by standard work up. [2019]
Evaluation of [89Zr]trastuzumab-PET/CT in differentiating HER2-positive from HER2-negative breast cancer. [2022]
[89Zr]Trastuzumab: Evaluation of Radiation Dosimetry, Safety, and Optimal Imaging Parameters in Women with HER2-Positive Breast Cancer. [2022]
Development and evaluation of 89Zr-trastuzumab for clinical applications. [2023]
First-in-Human Human Epidermal Growth Factor Receptor 2-Targeted Imaging Using 89Zr-Pertuzumab PET/CT: Dosimetry and Clinical Application in Patients with Breast Cancer. [2019]
Monitoring afatinib treatment in HER2-positive gastric cancer with 18F-FDG and 89Zr-trastuzumab PET. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security