HER2-PET Imaging Using 89Zr-trastuzumab in Low HER2-expressing (HER2-low) Breast Cancers
New PET Scan to Detect HER2-Low Breast Cancer
Plain English Summary
HER2-PET Imaging in HER2-low Breast Cancers is a Phase 2 clinical trial sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke studying Breast Cancer Metastatic. This trial tests a new type of PET scan using a special tracer to find breast cancer cells that have low levels of a protein called HER2. It is for patients with metastatic breast cancer that has spread and is considered HER2-low. Participants will receive an injection of the tracer and have a PET scan a few days later. Standard treatments for HER2-low breast cancer are available, and this scan aims to improve how we identify patients who might benefit from them. The trial aims to enroll 40 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have metastatic breast cancer that is HER2-low and are at least 18 years old. You must be able to lie still for at least 30 minutes for the scan. You cannot join if you are pregnant or breastfeeding. You cannot join if you have severe liver or kidney problems, or if you are allergic to trastuzumab or desferrioxamine. This trial is studying Breast Cancer Metastatic, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the new PET scan can detect HER2-low breast cancer, which could lead to more accurate staging and treatment decisions for patients. The specific primary outcome measures are: Evaluate 89Zr-trastuzumab PET imaging in a HER2-low breast cancer patient cohort (18 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial matters because it could help doctors better identify patients with HER2-low breast cancer, a group that is increasingly benefiting from new targeted therapies. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer Metastatic, where improved treatment options are needed.
Investor Insight
This trial explores a novel diagnostic tool for a growing segment of the breast cancer market, potentially guiding the use of expensive targeted therapies and immunotherapies. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this PET scan is right for you and how it might change your treatment plan. Participation involves receiving an injection and undergoing a PET scan. You will need to be available for the scan a few days after the injection. You will need to provide written consent to participate. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 40 participants
Interventions
- DIAGNOSTIC_TEST: 89Zr-trastuzumab — Patients will receive an intravenous dose of 0.5 MBq/kg (max 60 MBq) of 89Zr-trastuzumab in order to perform a PET imaging session 3-6 days later.
Primary Outcomes
- Evaluate 89Zr-trastuzumab PET imaging in a HER2-low breast cancer patient cohort (18 months)
Full 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.
Trial Locations
- Centre de recherche du CHUS, Sherbrooke, Quebec, Canada
Frequently Asked Questions
What is clinical trial NCT06732336?
NCT06732336 is a Phase 2 INTERVENTIONAL study titled "HER2-PET Imaging in HER2-low Breast Cancers." It is currently recruiting and is sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke. The trial targets enrollment of 40 participants.
What conditions does NCT06732336 study?
This trial investigates treatments for Breast Cancer Metastatic. The primary condition under study is Breast Cancer Metastatic.
What treatments are being tested in NCT06732336?
The interventions being studied include: 89Zr-trastuzumab (DIAGNOSTIC_TEST). Patients will receive an intravenous dose of 0.5 MBq/kg (max 60 MBq) of 89Zr-trastuzumab in order to perform a PET imaging session 3-6 days later.
What does Phase 2 mean for NCT06732336?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06732336?
This trial is currently "Recruiting." It started on 2024-12-01. The estimated completion date is 2027-03-31.
Who is sponsoring NCT06732336?
NCT06732336 is sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06732336?
The trial aims to enroll 40 participants. The trial is currently recruiting and accepting new participants.
How is NCT06732336 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06732336?
The primary outcome measures are: Evaluate 89Zr-trastuzumab PET imaging in a HER2-low breast cancer patient cohort (18 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06732336 being conducted?
This trial is being conducted at 1 site, including Sherbrooke, Quebec (Canada).
Where can I find official information about NCT06732336?
The official record for NCT06732336 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06732336. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06732336 testing in simple terms?
This trial tests a new type of PET scan using a special tracer to find breast cancer cells that have low levels of a protein called HER2. It is for patients with metastatic breast cancer that has spread and is considered HER2-low.
Why is this trial significant?
This trial matters because it could help doctors better identify patients with HER2-low breast cancer, a group that is increasingly benefiting from new targeted therapies.
What are the potential risks of participating in NCT06732336?
The main risk is an allergic reaction to the tracer, though this is uncommon. Potential side effects are generally related to the PET scan procedure itself, such as mild discomfort at the injection site. There is a small risk of radiation exposure from the PET scan, which is carefully managed. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06732336?
Ask your doctor if this PET scan is right for you and how it might change your treatment plan. Participation involves receiving an injection and undergoing a PET scan. You will need to be available for the scan a few days after the injection. You will need to provide written consent to participate. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06732336 signal from an investment perspective?
This trial explores a novel diagnostic tool for a growing segment of the breast cancer market, potentially guiding the use of expensive targeted therapies and immunotherapies. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive an injection of the tracer and have a PET scan a few days later. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Breast Cancer Metastatic Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.