Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advan… (NCT04273555) | Clinical Trial Compass
WithdrawnPhase 1/2
Monitoring Early Response to Targeted Therapy in Stage IV HER2+ Breast Cancer Patients With Advanced PET/MR Imaging
Stopped: Unable to recruit for this study.
United States0Started 2026-03-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Baseline measure of PET standardized uptake value (SUV).
Timeframe: Baseline imaging visit 1
2
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Timeframe: Baseline imaging visit 1
3
Baseline measure of signal enhancement ratio (SER) from MRI.