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

Running, not enrolling · Not applicable

Conditions studied: Bone Metastases, HER2-positive Breast Cancer, Liver Metastases, Lung Metastases, Recurrent Breast Cancer, Soft Tissue Metastases, Stage IV Breast Cancer

In brief

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.

Key facts

Study ID

NCT02226276

Run by

City of Hope Medical Center

People needed

10

Starts

2015-01-07

Expected to finish

2026-09-29

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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