Status:
COMPLETED
PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Brief Summary
RATIONALE: Diagnostic procedures, such as PET scans, may help in learning how well hormone therapy and trastuzumab work to kill breast cancer cells and allow doctors to plan better treatment. PURPOSE...
Detailed Description
OBJECTIVES: * Correlate the percent change in fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) standardized uptake value (SUV) and percent change in cell proliferation (as assessed by tu...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed breast cancer with 1 of the following:
- Hormone receptor-positive disease and planning to receive treatment with neoadjuvant aromatase inhibitor and ovarian suppression therapy (if premenopausal)
- Recurrent and/or metastatic hormone receptor-positive disease and planning to receive treatment with an aromatase inhibitor and ovarian suppression therapy (if premenopausal)
- Metastatic HER-2/neu-positive disease and planning to receive treatment with neoadjuvant trastuzumab (Herceptin®)
- Recurrent HER-2/neu-positive disease and planning to receive treatment with trastuzumab (Herceptin®)
- Tumor must be accessible for biopsy and assessable for response
- Tissue block must be available for review of experimental markers or patient must be willing to undergo biopsy
- Evaluable disease by FDG-PET scan
- Available for positron emission tomography (PET) imaging with a clinical indication for PET scan
- May aslo be enrolled on an experimental nuclear imaging study of 16α-fluoroestradiol F 18-PET scan (if hormone positive)
- Concurrently receiving treatment (hormonal or other) for breast cancer
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Female or male
- Postmenopausal or premenopausal
- Life expectancy ≥ 2 months
- No uncontrolled diabetes mellitus or other comorbidity that would preclude imaging
- Not pregnant
- Negative pregnancy test
- Able to tolerate scanning (e.g., no claustrophobia or severe pain)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent participation on another clinical study or other imaging studies allowed
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00362973
Start Date
May 1 2006
Last Update
December 28 2016
Active Locations (2)
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1
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
2
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109-1024