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Life sciences · Interventional Study
ClinicalTrials.gov · November 3, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT02226276). This is a study registration, not published results. Lead sponsor: City of Hope Medical Center. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 10 participants (ACTUAL). Conditions: Bone Metastases, HER2-positive Breast Cancer, Liver Metastases, Lung Metastases, Recurrent Breast Cancer, Soft Tissue Metastases, Stage IV Breast Cancer. Interventions: RADIATION: fludeoxyglucose F 18; PROCEDURE: positron emission tomography; PROCEDURE: computed tomography; BIOLOGICAL: trastuzumab; RADIATION: copper Cu 64-DOTA-trastuzumab; PROCEDURE: positron emission tomography; BIOLOGICAL: ado-trastuzumab emtansine; OTHER: laboratory biomarker analysis. Primary outcome measures: Relationship Between Average Tumor Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response , Baseline; Relationship Between Tumor Minimum Uptake of Copper Cu 64-DOTA-trastuzumab as Measured by PET and Patient Best Response , Up to 1 year. Brief summary: This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer that has spread to other places in the body. Copper Cu 64-DOTA-trastuzumab is a chemotherapy drug (trastuzumab) attached to a radioactive substance. Diagnostic procedures using PET may allow scanners to take pictures of where the drug travels in the body and may help doctors identify which patients may benefit from treatment with ado-trastuzumab emtansine.