Active Not RecruitingNot applicableNCT02226276

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

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.

Checked against the public recordLast updated Feb 13, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhaseNot applicable
U.S. locations1
SponsorCity of Hope Medical Center
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
City of Hope Medical Center
Interventions being studied
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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained prior to initiation of chemotherapy; it should be performed within 28 days prior to enrollment (patients with a biopsy of recurrent disease that is HER2-positive and have not received HER2-directed therapy since the biopsy can exceed the 28-day window up to 6 months); patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible) * At least 1 site of metastasis \>= 20 mm in mean diameter must be identified * The cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH) * Patients may not have received trastuzumab within 6 weeks of projected 64Cu-DOTA-trastuzumab/PET-CT * Participants must have normal cardiac ejection fraction * Ability to provide informed consent * Patients that may need dose reduction to commence cycle 1 treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Negative serum pregnancy test (female of childbearing potential only) * Patients must have adequate cardiac function; left ventricular ejection fraction (LVEF) \>= 50% as determined by multi gated acquisition (MUGA) scan or echocardiogram Exclusion Criteria: * Participants who have received trastuzumab within the prior 36 days * Participants who are not considered candidates for ado-trastuzumab-emtansine * No metastatic sites \>= 20 mm * Concurrent malignancy other than skin cancer - Inability to provide informed consent

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Medical CenterDuarte, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2026. Always confirm current availability with the study team.

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