PET Scan with Copper Cu 64-DOTA-Trastuzumab for Breast Cancer
What You Need to Know Before You Apply
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 treatmentPURPOSE: 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.
Is Copper Cu 64-DOTA-Trastuzumab safe for use in humans?
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.12346
What data supports the effectiveness of the treatment copper Cu 64-DOTA-trastuzumab for breast cancer?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Follow-up
Participants are monitored for safety and effectiveness after PET scans.
What Are the Treatments Tested in This Trial?
Interventions
- copper Cu 64-DOTA-trastuzumab
- positron emission tomography
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor