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NCT02226276 · ClinicalTrials.gov registry record · NA
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
A NA study of HER2-positive Breast Cancer and Stage IV Breast Cancer, sponsored by City of Hope Medical Center.
- Active
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02226276: Active NA study of HER2-positive Breast Cancer and Stage IV Breast Cancer, sponsored by City of Hope Medical Center.
NCT02226276 is a NA study of HER2-positive Breast Cancer and Stage IV Breast Cancer that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 10 participants, below the 236-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02226276, a NA study of HER2-positive Breast Cancer and Stage IV Breast Cancer, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Relationship between patient best response to T-DM1 and measured tumor uptake of 64Cu-DOTA-trastuzumab employed a t-test with a 0.05 two-sided significance level comparing average uptake in responsive vs non-responsive patients. Tumor uptake measured as SUV defined as SUV = AC(tsc) Wb /\[Dinj exp(-λ(tsc - tinj)\] , where AC(tsc) is the activity concentration in the volume of interest (VOI, e. g., a tumor), Wb is the patient's body weight, Dinj is the activity injected at time tinj, and λ is the
Conditions Studied
Interventions
- RADIATION fludeoxyglucose F 18
- PROCEDURE positron emission tomography
- PROCEDURE computed tomography
- BIOLOGICAL trastuzumab
- RADIATION copper Cu 64-DOTA-trastuzumab
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-01-07 |
| Est. Completion | 2026-09-29 |
| Phase | NA |
What the registry record for NCT02226276 still lists
NCT02226276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 236-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 7 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which fludeoxyglucose F 18 is the first listed.
NCT02226276 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02226276 about?
NCT02226276 is a clinical study titled "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 bre...
What is the current status of trial NCT02226276?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2015-01-07. Estimated completion is 2026-09-29.
What conditions does trial NCT02226276 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer, Stage IV Breast Cancer, Liver Metastases, Recurrent Breast Cancer, Bone Metastases.
What interventions are being tested in trial NCT02226276?
The interventions under investigation include: fludeoxyglucose F 18 (RADIATION), positron emission tomography (PROCEDURE), computed tomography (PROCEDURE), trastuzumab (BIOLOGICAL), copper Cu 64-DOTA-trastuzumab (RADIATION).
Who is sponsoring clinical trial NCT02226276?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02226276 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02226276's enrollment target sits among peer trials
10 58th of 58 higher than 1 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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