monitoring early response to targeted therapy in stage iv her2+ breast cancer patients with advanced pet/mr imaging

Conditions: HER2-positive Breast Cancer

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.

the purpose of this study is to see if a new group of imaging tests can help identify response to stage iv human epidermal growth factor receptor 2 positive (her2+) breast cancer before and during treatment. this study will test a new method for monitoring treatment. the investigators will use \[18f\]-fluorodeoxyglucose (fdg) positron emission tomography (pet)/magnetic resonance imaging (mri) to look at previously diagnosed stage iv breast cancer and image up to three times during therapy. fdg is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. however, the role of fdg-pet/mri for imaging response in breast cancer is not currently clear. pet/mri is a new imaging technique that combines pet and mri into a single study.

Eligibility criteria:
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)

Keywords: fdg-pet mri quantitative imaging