PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer
NCT ID: NCT00362973
Last Updated: 2016-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2006-05-31
Brief Summary
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PURPOSE: This clinical trial is studying how well PET scans work in assessing response to treatment in patients receiving hormone therapy or trastuzumab for breast cancer.
Detailed Description
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* 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 tumor biopsy) during hormonal therapy with tumor response in patients with hormone receptor-positive (estrogen receptor or progesterone receptor) breast cancer.
* Correlate the percent change in FDG-PET SUV and percent change in cell proliferation (as assessed by tumor biopsy) during treatment with trastuzumab (Herceptin®) with tumor response in patients with HER-2/neu-positive breast cancer.
* Compare the association between two-week changes in cell proliferation rate (as measured by FDG-PET and biopsy) in patients treated with an aromatase inhibitor or trastuzumab.
OUTLINE: Patients are assigned to 1 of 2 groups according to therapy.
* Group 1 (patients receiving hormonal therapy): Patients undergo fludeoxyglucose F 18-positron emission tomography (FDG-PET) scan and may also undergo 16α-fluoroestradiol F 18 (FES)-PET scan at baseline (prior to beginning therapy) and FDG-PET scan 2 weeks after beginning therapy.
Blood samples are collected at baseline and at 3 and 6 months after beginning aromatase inhibitor therapy. The blood samples are examined for hormone levels, including estradiol, estrone, testosterone, follicle-stimulating hormone, and sex hormone-binding globulin.
* Group 2 (patients receiving HER-2/neu targeted therapy): Patients undergo biopsy and FDG-PET scan at baseline (prior to beginning therapy) and FDG-PET scan 1-2 weeks after beginning therapy.
Some patients undergo a core-needle biopsy 2 weeks after beginning therapy. Biopsies are assessed for the following markers: proliferative rate (Ki67), estrogen receptor, progesterone receptor, HER-2/neu, epidermal growth factor receptor, androgen receptor, and topoisomerase II.
After completion of study therapy, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Hormone Receptor Positive Breast Cancer
Patients with hormone receptor positive primary, recurrent or metastatic breast cancer with a treatment plan that involves (neoadjuvant) administration of aromatase inhibitor and ovarian suppression (if premenopausal).
laboratory biomarker analysis
needle biopsy
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
HER-2/neu Positive Breast Cancer
Patients with HER-2/neu positive primary, recurrent or metastatic breast cancer with a treatment plan that involves (neoadjuvant) administration of trastuzumab.
laboratory biomarker analysis
needle biopsy
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Interventions
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laboratory biomarker analysis
needle biopsy
positron emission tomography
radionuclide imaging
fludeoxyglucose F 18
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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FHCRC
Principal Investigators
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Hannah M. Linden, MD
Role: PRINCIPAL_INVESTIGATOR
Seattle Cancer Care Alliance
Locations
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Seattle Cancer Care Alliance
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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UWCC-6213
Identifier Type: -
Identifier Source: secondary_id
UWCC-06-0445-H/D
Identifier Type: -
Identifier Source: secondary_id
CDR0000492255
Identifier Type: REGISTRY
Identifier Source: secondary_id
6213
Identifier Type: -
Identifier Source: org_study_id