GE 280-401

Primary Objective:
a) To measure the proportion of breast cancer patients where Cerianna positron emission tomography (PET)/computed tomography (CT) detection of estrogen receptor (ER) status alters the preexamination intended therapeutic management
Secondary Objectives:
a) Per subject, to qualitatively assess heterogeneity in tumor Cerianna uptake relative to standard-of-care imaging
b) Per subject, to quantitatively assess heterogeneity in tumor Cerianna uptake c) To evaluate the relationship between heterogeneity in tumor Cerianna uptake and the change in therapeutic management plan
d) To measure the treating physicians confidence in therapeutic management plan before and after Cerianna PET/CT
e) To measure the proportion of breast cancer patients for whom Cerianna PET/CT leads to a change of actual therapeutic management by comparing the therapeutic management plans to the actual therapeutic management at 6 months and at 18 months after Cerianna PET/CT f) To evaluate progression-free survival (PFS) at 6 and 18 months based on heterogeneity in tumor Cerianna uptake. Comparison will be made between patients with and without a change in treatment management plan
Exploratory Objectives:
a) To assess the patients quality of life at 6 and 18 months compared to screening (baseline). Comparison will be made between patients with and without a change in treatment management plan based on heterogeneity in tumor Cerianna uptake b) To determine a heterogeneity threshold for tumor Cerianna uptake that can inform the therapeutic management decision
c) Change in therapeutic management plan based on heterogeneity in tumor Cerianna uptake will be assessed in the following subgroups:
a. Oligometastatic (5 lesions or less) / polymetastatic (5 lesions) b. Ductal / lobular cancer
c. Bone-only metastases / other metastases d. ER-low-positive (1 to 9%) / ER-positive (10% or more) e. Progression 12 months / 12 months from 1st line hormonal treatment initiation f. First-line therapy with cyclin-dependent kinase (CDK) 4/6 inhibitor / without CDK4/6 inhibitor
g. With standard-of-care biopsy results from at least 1 metastatic lesion available before Cerianna PET/CT / without metastatic Primary Endpoint: a. Proportion of patients with a change in therapeutic management plan assessed by comparing pre- and post-Cerianna PET/CT treatment selection (based on comparison of the initial therapeutic management plan and post-Cerianna therapeutic PET/CT management plan evaluated within 3 weeks after Cerianna PET/CT) Secondary Endpoints: a. Number and percentage of lesions detected with Cerianna PET/CT (focal Cerianna uptake, outside the liver, visible above background) in individual patients. Cerianna-uptake score per patient, defined as total number of Cerianna-positive lesions divided by all lesions visible on standard-of-care imaging (e.g., CT and/or bone scan, or FDG-PET/CT) and Cerianna PET/CT (lower scores represent greater ER heterogeneity/ER loss; 0 = a negative scan) b. Standard uptake values (SUVs, incl. SUVmax, SUVmean, SUVpeak) of each measurable lesion on Cerianna PET/CT and the inter-lesion variability of Cerianna uptake in individual patients c. Association between Cerianna heterogeneity scores (inter-lesion SUV variability and Cerianna-uptake score) and patients with/without change in therapeutic management plan d. Treating physicians confidence level in the therapeutic management plan (measured on a 10-point scale) and the percent change in confidence level before and after Cerianna PET/CT e. Proportion of patients with a change in actual therapeutic management assessed by comparing the therapeutic management plans to the actual therapeutic management at 6 months and 18 months after Cerianna PET/CT
f. PFS rate at 6 and 18 months based on heterogeneity in tumor Cerianna uptake. Comparison will be made between patients with and without a change in therapeutic managemen

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: - 99 Years
• Gender: All