NCT02226276Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
A Pilot Study of 64Cu-DOTA-Trastuzumab Positron Emission Tomography in Treatment of Advanced HER2 Positive Breast Cancer With the Antibody Drug Conjugate Ado-trastuzumab Emtansine
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 25 Aug 2014
- Start date
- 25 Feb 2015
- Primary completion date
- 7 Dec 2021
- Lead sponsor
- City of Hope Medical Center
- Diseases
- Lung cancer, Metastatic breast cancer
- NCT number
- NCT02226276
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From 25 Feb 2015 to the primary completion date, 7 Dec 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have received trastuzumab within the prior 36 days
- Concurrent malignancy other than skin cancer - Inability to provide informed consent
Other
- Participants who are not considered candidates for ado-trastuzumab-emtansine
- No metastatic sites \>= 20 mm
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.