Clinical trial NCT01996046: FDG PET/CT in Breast Cancer Bone Mets
Official title: 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) for the Evaluation of Response to Therapy in Bone-dominant Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Estrogen Receptor Positive Breast Cancer
Bone Metastases
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a history of ER+ breast cancer with documented bone metastases from breast cancer. Patients must be planning to start new hormone therapy for their breast cancer.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival
timeFrame: medical record reviewed every 6 months from date of enrollment to date of progression, up to 120 months
Secondary outcomes:
measure: Overall Survival
timeFrame: medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months
Other outcomes:
measure: Number of patients who have a Skeletal Related Event
timeFrame: medical record reviewed every 6 months from date of enrollment to date of death, up to 120 months
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: David Mankoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: