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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| UWCC-6213 | |||
| UWCC-06-0445-H/D | |||
| CDR0000492255 | Registry Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
OUTLINE: Patients are assigned to 1 of 2 groups according to 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other |
| ||
| needle biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in fludeoxyglucose F 18-positron emission tomography (FDG-PET) standardized uptake value and change in markers of proliferation (Ki67) at 2 weeks | 2 weeks | |
| Percent change in cell proliferation correlated with absolute measures of FDG-PET | 2 weeks | |
| Correlation of early FDG-PET with response prediction | 6 months |
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DISEASE CHARACTERISTICS:
Newly diagnosed breast cancer with 1 of the following:
Tumor must be accessible for biopsy and assessable for response
Evaluable disease by FDG-PET scan
Available for positron emission tomography (PET) imaging with a clinical indication for PET scan
Concurrently receiving treatment (hormonal or other) for breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Patients with primary, recurrent or metastatic breast cancer that is either hormonal receptor positive or HER-2/neu positive.
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| Name | Affiliation | Role |
|---|---|---|
| Hannah M. Linden, MD | Seattle Cancer Care Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | United States | ||
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
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| Procedure |
|
| positron emission tomography | Procedure |
|
| radionuclide imaging | Procedure |
|
| fludeoxyglucose F 18 | Radiation |
|
| Seattle |
| Washington |
| 98109-1024 |
| United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018567 | Breast Neoplasms, Male |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| D009682 | Magnetic Resonance Spectroscopy |
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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