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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:
ClinicalTrials.gov Identifier:
NCT00362973
First Posted: August 15, 2006
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Washington
  Purpose

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.


Condition Intervention
Breast Cancer Other: laboratory biomarker analysis Procedure: needle biopsy Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Assessment of Response to Targeted Breast Cancer Therapy

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Percent change in fludeoxyglucose F 18-positron emission tomography (FDG-PET) standardized uptake value and change in markers of proliferation (Ki67) at 2 weeks [ Time Frame: 2 weeks ]
  • Percent change in cell proliferation correlated with absolute measures of FDG-PET [ Time Frame: 2 weeks ]
  • Correlation of early FDG-PET with response prediction [ Time Frame: 6 months ]

Enrollment: 42
Study Start Date: May 2006
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
Other: laboratory biomarker analysis Procedure: needle biopsy Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18
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.
Other: laboratory biomarker analysis Procedure: needle biopsy Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18

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-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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with primary, recurrent or metastatic breast cancer that is either hormonal receptor positive or HER-2/neu positive.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362973


Locations
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Hannah M. Linden, MD Seattle Cancer Care Alliance
  More Information

Responsible Party: Hannah Linden, MD, FHCRC
ClinicalTrials.gov Identifier: NCT00362973     History of Changes
Other Study ID Numbers: 6213
P30CA015704 ( U.S. NIH Grant/Contract )
UWCC-6213
UWCC-06-0445-H/D
CDR0000492255 ( Registry Identifier: PDQ )
First Submitted: August 10, 2006
First Posted: August 15, 2006
Last Update Posted: December 28, 2016
Last Verified: May 2013

Keywords provided by University of Washington:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Trastuzumab
Fluorodeoxyglucose F18
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action