Clinical trial · Interventional
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
Monitoring Early Response to Targeted Therapy in Stage IV Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Patients With Advanced Positron Emission Tomography (PET)/Magnetic Resonance Imaging (MRI)
NCT04273555CI-TRIAL-00116508withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit for this study.
Summary
Brief summary (as posted)
The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-FDG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]-Fluorodeoxyglucose (FDG) PET/ MRI
- interventionNames
- Drug: [18F]-FDG
Primary outcomes (6)
- measure
- Baseline measure of PET standardized uptake value (SUV).
- timeFrame
- Baseline imaging visit 1
- description
- Compare baseline metrics from PET/MRI
- measure
- Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
- timeFrame
- Baseline imaging visit 1
- description
- Compare baseline metrics from PET/MRI
- measure
- Baseline measure of signal enhancement ratio (SER) from MRI.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be ≥ 18 years old and ≤ 75 years old * Patients with HER2+ metastatic breast cancer * HER2-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH) (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility * Estrogen/progesterone receptor positive OR negative disease allowed * Patients must have measurable disease in one metastatic lesion per RECIST v 1.1 * Stage IV HER2+ breast cancer patients eligible for a new therapeutic regimen that includes HER2-targeted treatment who are naïve to that regimen * Estimated life expectancy of greater than six months Exclusion Criteria: * Children, less than 18 years of age, will be excluded from this study * Metastatic breast cancer patients who are HER2 positive and have already started their current HER2-targeted therapy regimen for metastatic disease * Patients who have not recovered from grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment * Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment * Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent). * Patients found to have constitutionally present non-magnetic resonance (MR) compatible ferromagnetic materials * Unable to lie still on the imaging table for one (1) hour * Inability to receive gadolinium-based contrast agent * Patients for whom a PET/MRI is technically not feasible (e.g. breast volume, obesity, \> body mass index (BMI) 36)
References
Publications (0)
Data not yet available
No reference posted for this study.