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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00362973
First received: August 10, 2006
Last updated: May 15, 2013
Last verified: May 2013

August 10, 2006
May 15, 2013
May 2006
November 2009   (final data collection date for primary 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 [ Designated as safety issue: No ]
  • Percent change in cell proliferation correlated with absolute measures of FDG-PET [ Designated as safety issue: No ]
  • Correlation of early FDG-PET with response prediction [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00362973 on ClinicalTrials.gov Archive Site
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PET Scans in Assessing Response To Treatment in Patients Receiving Hormone Therapy or Trastuzumab for Breast Cancer
Early Assessment of Response to Targeted Breast Cancer Therapy

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:

  • 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.

Interventional
Not Provided
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
  • Other: laboratory biomarker analysis
  • Procedure: needle biopsy
  • Procedure: positron emission tomography
  • Procedure: radionuclide imaging
  • Radiation: F-18 16 alpha-fluoroestradiol
  • Radiation: fludeoxyglucose F 18
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00362973
6213, P30CA015704, UWCC-6213, UWCC-06-0445-H/D, CDR0000492255
Not Provided
Hannah Linden, MD, FHCRC
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Hannah M. Linden, MD Seattle Cancer Care Alliance
University of Washington
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP