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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of PET scan using copper Cu 64-DOTA-trastuzumab to help doctors better plan treatments for women with HER2-positive breast cancer. The goal is to evaluate how effectively this technique identifies cancer spread to areas such as the lungs, liver, soft tissue, or bones. Women with metastatic HER2-positive breast cancer who haven't recently received certain treatments may qualify for this study. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance future cancer treatment planning.

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 prior data suggests that this diagnostic procedure is safe for breast cancer patients?

Research shows that using copper Cu 64-DOTA-trastuzumab in PET scans for breast cancer is generally safe. Studies have found that patients experienced no allergic reactions or major side effects from this treatment. In one study, eight patients underwent repeat scans without any problems. Another study with a similar compound, 64Cu-NOTA-Trastuzumab, also reported no side effects, suggesting that similar compounds are well-tolerated. Overall, the evidence indicates that this imaging method is safe and well-tolerated in people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about copper Cu 64-DOTA-trastuzumab for breast cancer because it offers a new way to visualize how the cancer is behaving in the body. Unlike traditional treatments that target the cancer directly, this approach uses a PET scan with a specialized tracer to see how the cancer cells are responding to therapy. This could allow doctors to tailor treatments more effectively and quickly, potentially leading to better outcomes for patients. By using this method, they hope to refine and personalize breast cancer treatment strategies.

What evidence suggests that this PET scan is effective for breast cancer?

Studies have shown that a copper Cu 64-DOTA-trastuzumab PET scan can successfully image HER2-positive breast cancer. This scan helps doctors understand the cancer's behavior and treatment response. Research indicates that copper Cu 64 enhances image clarity by attaching to cancer cells with the HER2 protein. Previous findings suggest this method safely and effectively reveals cancer locations in the body. In this trial, participants will undergo this PET scan to provide doctors with a detailed view of the cancer, aiding in better treatment planning. ^{2 4 6 7 8}

Who Is on the Research Team?

Joanne Mortimer

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02226276

Copper Cu 64-DOTA-Trastuzumab PET in Predicting ... This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9185799/

Copper-64 trastuzumab PET imaging: A reproducibility study Recent work has reported successful imaging of breast cancer using 64Cu-trastuzumab (19, 20), which has a 12.7-hour half-life. The use of 64Cu may enable ...

3. nature.com nature.com/articles/s41598-020-77397-0

Towards integration of 64Cu-DOTA-trastuzumab PET-CT ... We present the results of utilizing a biophysical mathematical model to predict tumor response for two HER2 + breast cancer patients treated ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/55/1/23

Functional Imaging of Human Epidermal Growth Factor ... Results: Liver uptake of 64Cu was reduced approximately 75% with the 45-mg trastuzumab predose, without significant effect on tumor uptake. The ...

5. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-021-00746-1

A preliminary clinical trial to evaluate 64 Cu-NOTA ... This preliminary clinical trial showed that 64Cu-NOTA-Trastuzumab PET is both safe and feasible. 64Cu-NOTA-Trastuzumab showed a specific uptake ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02226276

NCT02226276 | Copper Cu 64-DOTA-Trastuzumab PET in ... Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7818354/

A preliminary clinical trial to evaluate 64Cu-NOTA ... No adverse events related to 64Cu-NOTA-Trastuzumab were reported. The calculated effective dose with a 296 MBq injection of 64Cu-NOTA-Trastuzumab was 2.96 mSv.

8. jnm.snmjournals.org jnm.snmjournals.org/content/60/1/26

Development of 64Cu-NOTA-Trastuzumab for HER2 Targeting Uptake of 64Cu-NOTA-trastuzumab was highest at 48 h after injection as determined by PET imaging and biodistribution results in BT-474 tumors.