Early Assessment of Response to Targeted Breast Cancer Therapy
18 Years
N/A
Both
Breast Cancer
Trial Information
Early Assessment of Response to Targeted Breast Cancer Therapy
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 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Percent change in fludeoxyglucose F 18-positron emission tomography (FDG-PET) standardized uptake value and change in markers of proliferation (Ki67) at 2 weeks
Safety Issue:
No
Principal Investigator
Hannah M. Linden, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seattle Cancer Care Alliance
Authority:
United States: Federal Government
Study ID:
6213
NCT ID:
NCT00362973
Start Date:
May 2006
Completion Date:
Related Keywords:
- Breast Cancer
- male breast cancer
- recurrent breast cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
