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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 6 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Feb 13, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.
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.