Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00362973
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2006-08-10
Brief Title:
PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Early Assessment of Response to Targeted Breast Cancer Therapy
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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:
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-2neu-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-2neu 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-2neu 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
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-2neu-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-2neu 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-2neu 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000492255 | REGISTRY | PDQ | httpsreporternihgovquickSearchP30CA015704 |
| P30CA015704 | NIH | None | None |
| UWCC-6213 | None | None | None |
| UWCC-06-0445-HD | None | None | None |