89Zr-ss-pertuzumab Imaging for Breast Cancer

Recruiting at 7 trial locations

Overseen By Randy Yeh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Life expectancy < 3 months, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 20 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.

Do I need to stop my current medications for the trial?

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-ss-pertuzumab for breast cancer?

Research shows that 89Zr-pertuzumab, a component of 89Zr-ss-pertuzumab, is effective in imaging HER2-positive breast cancer, helping to identify patients who may benefit from targeted therapies. It has been successful in detecting HER2-positive metastases even in patients with HER2-negative primary breast cancer, which can guide treatment decisions. ^{1 2 3 4 5}

Is 89Zr-ss-pertuzumab safe for use in humans?

In a study involving patients with HER2-positive breast cancer, 89Zr-pertuzumab was administered without any toxicities, indicating it was safe for human use in this context. ^{1 2 4 5 6}

How does the drug 89Zr-ss-pertuzumab differ from other breast cancer treatments?

89Zr-ss-pertuzumab is unique because it is used for imaging rather than direct treatment, helping to identify HER2-positive breast cancer metastases that might not be detected by other methods. This drug is radiolabeled with zirconium-89, allowing it to be used in PET/CT scans to visualize cancer spread and assess HER2 status, which is crucial for determining the appropriate targeted therapy. ^{1 2 3 4 5}

Research Team

Somali Gavane, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with HER2+ breast cancer, as defined by specific medical guidelines or genetic testing. Participants must have at least one detectable cancer lesion and be in fair to good physical condition (ECOG 0-2). Pregnant or breastfeeding individuals, those with certain kidney or liver conditions, a life expectancy under three months, or who exceed the weight limit for PET/CT scans cannot join.

Inclusion Criteria

I am 18 years old or older.

My cancer is HER2 positive based on specific guidelines or tests.

My cancer has low HER2 levels, confirmed by specific tests.

Exclusion Criteria

Your liver enzymes (AST/ALT) are more than double the normal limit.

Pregnancy or lactation

Your kidney function, measured by a blood test called creatinine, is more than double the normal level.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 89Zr-ss-pertuzumab to evaluate its safety in HER2+ cancer

Up to 20 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 89Zr-ss-pertuzumab

Trial Overview The study is evaluating the safety of a new imaging agent called 89Zr-ss-pertuzumab used in PET/CT scans to identify cancer in patients with HER2+ breast cancer. It aims to determine if this agent can effectively highlight tumors during imaging.

Participant Groups

Group I: HER2-positive malignancy Experimental Treatment 1 Intervention

Participants will have a diagnosis of HER2-positive malignancy

Group II: HER2-low malignancy Experimental Treatment 1 Intervention

Participants will have a diagnosis of HER2-low malignancy

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

This first-in-human study involving 6 patients with HER2-positive metastatic breast cancer demonstrated that 89Zr-pertuzumab PET/CT is safe, with no reported toxicities during the trial.

The imaging technique effectively visualized HER2-positive metastases, confirming its potential for assessing HER2 status in lesions that are difficult to biopsy, and it accurately identified HER2-positive brain metastases in one patient, which was later confirmed by surgical resection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ulaner, GA., Lyashchenko, SK., Riedl, C., et al.[2019]

The study successfully developed an immuno-PET imaging agent, 89Zr-DFO-pertuzumab, which effectively binds to HER2 and allows for visualization of HER2-expressing tumors, demonstrating its potential to monitor therapeutic responses in breast cancer.

In trastuzumab-resistant JIMT-1 breast cancer models, 89Zr-DFO-pertuzumab showed significantly reduced uptake in tumors treated with the HSP90 inhibitor 17-DMAG, indicating its ability to assess treatment efficacy and HER2 downregulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Response Monitoring with 89Zr-DFO-Pertuzumab in HER2-Positive and Trastuzumab-Resistant Breast Cancer Models. Kang, M., Shin, JI., Han, S., et al.[2022]

Pertuzumab is an effective treatment for metastatic HER2-positive breast cancer, especially when combined with trastuzumab and docetaxel, showing significant improvements in progression-free and overall survival in treatment-naive patients.

As a HER dimerization inhibitor, pertuzumab works differently than trastuzumab, allowing for a more complete blockade of HER2 signaling, and has a tolerable safety profile, making it a recommended first-line therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pertuzumab for the treatment of human epidermal growth factor receptor type 2-positive metastatic breast cancer. Chung, C., Lam, MS.[2019]

References

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

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]

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

Imaging of HER2 with [89Zr]pertuzumab in Response to T-DM1 Therapy. [2020]

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

Identification of HER2-Positive Metastases in Patients with HER2-Negative Primary Breast Cancer by Using HER2-targeted 89Zr-Pertuzumab PET/CT. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic Response Monitoring with 89Zr-DFO-Pertuzumab in HER2-Positive and Trastuzumab-Resistant Breast Cancer Models. [2022]

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

Dual-labeled pertuzumab for multimodality image-guided ovarian tumor resection. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Pertuzumab for the treatment of human epidermal growth factor receptor type 2-positive metastatic breast cancer. [2019]