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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00602043 |
Purpose
RATIONALE: Diagnostic procedures, such as F-18 16 alpha-fluoroestradiol imaging, may help predict how well patients will respond to hormone therapy and may help plan the best treatment.
PURPOSE: This phase II trial is studying how well F-18 16 alpha-fluoroestradiol imaging works in predicting response to first-line hormone therapy in women with hormone receptor-positive metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Radiation: F-18 16 alpha-fluoroestradiol Radiation: fludeoxyglucose F 18 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | A Phase 2 Study of [18F]Fluoroestradiol (FES) as a Marker of Hormone Sensitivity of Metastatic Breast Cancer |
| Estimated Enrollment: | 38 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo clinical fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) or FDG-PET/CT scanning. Within 14 days later, patients undergo F-18 16 alpha-fluoroestradiol ([^18F] FES) PET scanning prior to initiation of hormone therapy.
Patients receive hormone therapy per standard therapy guideline 14 days after PET scans.
After completion of hormone therapy, patients are followed periodically for 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Disease may be measurable (by RECIST criteria) or non-measurable but must be present in at least one non-liver site and imageable on fludeoxyglucose F 18 PET scan
Patients with non-measurable disease by RECIST criteria, one of the following may be used to assess and follow disease
Tumor HER2/neu expression must be determined prior to study enrollment
Patients must be planning a course of endocrine therapy with one of the following:
Positive for estrogen receptor (ER) and may or may not be positive for progesterone receptor by IHC in the primary tumor and/or metastatic site
PATIENT CHARACTERISTICS:
Known menopausal status
Postmenopausal is defined as:
PRIOR CONCURRENT THERAPY:
Meets 1 of the following criteria:
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98109-1024 | |
| Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente 800-804-8824 | |
| Study Chair: | David A. Mankoff, MD, PhD | Seattle Cancer Care Alliance |
More Information
| Responsible Party: | David A. Mankoff, Seattle Cancer Care Alliance |
| ClinicalTrials.gov Identifier: | NCT00602043 History of Changes |
| Other Study ID Numbers: | 6590, P30CA015704, UWCC-6590, CDR0000584077 |
| Study First Received: | January 23, 2008 |
| Last Updated: | November 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV breast cancer recurrent breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |