PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Early Assessment of Response to Targeted Breast Cancer Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Procedure: needle biopsy
* Procedure: positron emission tomography
* Procedure: radionuclide imaging
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hormone Receptor Positive Breast Cancer<br>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). | Other: laboratory biomarker analysis<br> <br> Procedure: needle biopsy<br> <br> Procedure: positron emission tomography<br> <br> Procedure: radionuclide imaging<br> <br> Radiation: fludeoxyglucose F 18<br> <br> |
| HER-2/neu Positive Breast Cancer<br>Patients with HER-2/neu positive primary, recurrent or metastatic breast cancer with a treatment plan that involves (neoadjuvant) administration of trastuzumab. | Other: laboratory biomarker analysis<br> <br> Procedure: needle biopsy<br> <br> Procedure: positron emission tomography<br> <br> Procedure: radionuclide imaging<br> <br> Radiation: fludeoxyglucose F 18<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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