Bone Metastases, Estrogen Receptor Positive Breast Cancer
Conditions
Brief summary
This study will evaluate baseline uptake on a FDG PET/CT scan in patients with breast cancer that has spread to the bones. A repeat FDG PET/CT scan will be done 4 weeks after the start of new breast cancer hormone treatment and again at 12 weeks after treatment start. The baseline uptake and change in uptake after the repeat scans will be compared to clinical long term outcomes such as time to progression and overall survival. In addition the uptake will be compared to the incidence of skeletal related events that are common occurrences in patients with cancer that has spread to the bones.
Detailed description
This is an observational study as all patients will receive the same research diagnostic test, an FDG PET/CT study performed at 4 weeks after starting new hormone treatment.
Interventions
OTHERFDG PET/CT scan
\[18F\] FDG PET/CT scan at 4 weeks after starting new hormonal therapy
Sponsors
University of Pennsylvania
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients, at least 18 years of age, with a history of pathologically confirmed ER+ breast cancer 2. Biopsy proven or clinically obvious documented bone metastases from breast cancer (with the majority of the disease burden in the bone) 3. Patients planning to start new endocrine targeted therapy (any line of therapy is acceptable and any endocrine therapy is allowed) 4. Willing and able to comply with scheduled visits and serial imaging procedures 5. Agrees to allow access to clinical records regarding response to treatment and long term follow up. 6. Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines
Exclusion criteria
1. Women who are pregnant or breast feeding 2. Uncontrolled diabetes mellitus (fasting glucose greater than 200 mg/dL) 3. Inability to tolerate imaging procedures (e.g. claustrophobia, severe pain) 4. Weight exceeding capacity of imaging table 5. Previous treatment with radiation or surgery to a significant percentage of bony metastatic sites 6. Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor (GCSF)) within 3 weeks of baseline scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months | Date of clinical progression will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months | Date of death will be recorded |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who have a Skeletal Related Event | medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months | Occurrence of radiation therapy to stabilize skeletal disease, pathologic fracture,spinal cord compression, surgery to stabilize the skeleton or hypercalcemia of malignancy will be recorded |
Countries
United States
Outcome results
None listed