PET Scan with Copper Cu 64-DOTA-Trastuzumab for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Must not be taking: Trastuzumab

Disqualifiers: Single site metastasis, Concurrent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

Will I have to stop taking my current medications?

The trial requires that you have not taken trastuzumab (a cancer treatment) in the last 2 months, but it does not specify about other medications. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the treatment copper Cu 64-DOTA-trastuzumab for breast cancer?

Research shows that copper Cu 64-DOTA-trastuzumab can effectively bind to HER2-positive tumors, which are common in breast cancer, allowing for clear imaging of these tumors. This suggests it could be useful in identifying and monitoring HER2-positive breast cancer. ^{1 2 3 4 5}

Is Copper Cu 64-DOTA-Trastuzumab safe for use in humans?

Studies have shown that Copper Cu 64-DOTA-Trastuzumab has been evaluated for safety in humans, particularly in patients with HER2-positive breast cancer, and it has been used safely for imaging purposes in clinical trials. ^{1 2 3 5 6}

How is the drug PET Scan with Copper Cu 64-DOTA-Trastuzumab unique for breast cancer treatment?

This drug is unique because it combines trastuzumab, a monoclonal antibody that targets HER2-positive breast cancer cells, with a radioactive copper-64 label, allowing for precise imaging of cancer cells using PET scans. This approach not only helps in targeting the cancer cells but also provides a non-invasive way to assess HER2 expression across the entire tumor, which can guide treatment decisions. ^{1 2 3 6 7}

Research Team

Joanne Mortimer

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for women with advanced HER2-positive breast cancer that has spread beyond the original tumor and axilla. They must have a biopsy confirming metastasis, not received trastuzumab in the last 2 months, and have at least one non-liver metastatic site over 2 cm. Participants need normal heart function and can't be pregnant or unable to consent.

Inclusion Criteria

I am a woman with breast cancer that has spread beyond the original area and underarm.

I have a cancer spread larger than 2 cm outside my liver.

My heart pumps blood normally.

Exclusion Criteria

I have another type of cancer besides skin cancer.

Participants who are pregnant

Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Determination

Patients are randomized to 1 of 3 dose levels and undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab.

1 week

Optimal Dose PET Scan

Patients undergo a PET scan 24-48 hours after injection of 64 Cu-DOTA-trastuzumab at the optimal dose determined in part one.

1 week

Follow-up

Participants are monitored for safety and effectiveness after PET scans.

4 weeks

Treatment Details

Interventions

• copper Cu 64-DOTA-trastuzumab
• positron emission tomography

Trial Overview The study tests a PET scan using copper Cu 64-DOTA-trastuzumab to see if it helps plan better treatments for breast cancer. It includes laboratory biomarker analysis, immunohistochemistry staining method, mutation analysis, and biopsies to assess the cancer's characteristics.

Participant Groups

Group I: Arm I Experimental Treatment 6 Interventions

PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Findings from Research

Trastuzumab, when labeled with (64)Cu and used in PET imaging, specifically targets and accumulates in non-small cell lung carcinoma (NSCLC) tumors that overexpress the Her2/neu gene, demonstrating its potential as a non-invasive imaging tool.

The study showed that (64)Cu-DOTA-trastuzumab had significantly higher uptake in Her2/neu positive tumors compared to negative ones, indicating its effectiveness in identifying patients who may benefit from trastuzumab therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging and biodistribution of Her2/neu expression in non-small cell lung cancer xenografts with Cu-labeled trastuzumab PET. Paudyal, P., Paudyal, B., Hanaoka, H., et al.[2019]

The study demonstrated that (64)Cu-DOTA-trastuzumab PET imaging is safe and effective for identifying HER2-positive tumors in breast cancer patients, with optimal imaging occurring 48 hours post-injection.

The radiation exposure from (64)Cu-DOTA-trastuzumab PET is comparable to that of conventional (18)F-FDG PET, and the imaging successfully detected brain metastases and primary tumors, indicating its potential for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

64Cu-DOTA-trastuzumab PET imaging in patients with HER2-positive breast cancer. Tamura, K., Kurihara, H., Yonemori, K., et al.[2022]

The study successfully optimized the labeling of trastuzumab with copper-64, achieving high radiochemical purity (>97%) for both DOTA-trastuzumab and NODAGA-trastuzumab, which are important for accurate imaging in HER2-positive breast cancer.

In a preliminary mouse model, both labeled tracers demonstrated significant tumor uptake (3-9% ID/g), indicating their potential effectiveness for imaging HER2-expressing tumors in cancer diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[(64) Cu]-labelled trastuzumab: optimisation of labelling by DOTA and NODAGA conjugation and initial evaluation in mice. Schjoeth-Eskesen, C., Nielsen, CH., Heissel, S., et al.[2021]

The study evaluated (64)Cu-DOTA-trastuzumab PET/CT in 8 women with HER2-positive metastatic breast cancer, showing high sensitivity for detecting tumors (77% to 93%) and effective imaging of HER2 expression without observed toxicities.

A 45-mg predose of trastuzumab significantly reduced liver uptake of the radiotracer, enhancing the imaging of tumors, indicating that this method could help personalize anti-HER2 therapies for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional imaging of human epidermal growth factor receptor 2-positive metastatic breast cancer using (64)Cu-DOTA-trastuzumab PET. Mortimer, JE., Bading, JR., Colcher, DM., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Imaging and biodistribution of Her2/neu expression in non-small cell lung cancer xenografts with Cu-labeled trastuzumab PET. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

64Cu-DOTA-trastuzumab PET imaging in patients with HER2-positive breast cancer. [2022]

3. England pubmed.ncbi.nlm.nih.gov

[(64) Cu]-labelled trastuzumab: optimisation of labelling by DOTA and NODAGA conjugation and initial evaluation in mice. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Copper-64 trastuzumab PET imaging: a reproducibility study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

A preliminary clinical trial to evaluate 64Cu-NOTA-Trastuzumab as a positron emission tomography imaging agent in patients with breast cancer. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Affinity-Guided Conjugation to Antibodies for Use in Positron Emission Tomography. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Functional imaging of human epidermal growth factor receptor 2-positive metastatic breast cancer using (64)Cu-DOTA-trastuzumab PET. [2022]