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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00602043 |
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 |
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Breast Cancer |
Drug: F-18 16 alpha-fluoroestradiol Drug: fludeoxyglucose F 18 |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
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 2009 (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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of metastatic breast cancer with biopsy of at least one site of disease
Disease must be measurable in at least one non-liver and non-bone site (by RECIST criteria) and imageable on fludeoxyglucose F 18 PET scan
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:
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 |
Responsible Party: | Seattle Cancer Care Alliance ( David A. Mankoff ) |
Study ID Numbers: | CDR0000584077, UWCC-6590 |
Study First Received: | January 23, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00602043 |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |