Early Assessment of Response to Targeted Breast Cancer Therapy
- 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
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
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
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.
Masking: Open Label, Primary Purpose: Diagnostic
Percent change in fludeoxyglucose F 18-positron emission tomography (FDG-PET) standardized uptake value and change in markers of proliferation (Ki67) at 2 weeks
Hannah M. Linden, MD
Seattle Cancer Care Alliance
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|