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
  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: F-18 16 alpha-fluoroestradiol
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
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 [ 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 ]

Enrollment: 42
Study Start Date: May 2006
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362973

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

Additional Information:
No publications provided

Responsible Party: Hannah Linden, MD, FHCRC
ClinicalTrials.gov Identifier: NCT00362973     History of Changes
Other Study ID Numbers: 6213, P30CA015704, UWCC-6213, UWCC-06-0445-H/D, CDR0000492255
Study First Received: August 10, 2006
Last Updated: May 15, 2013
Health Authority: United States: Federal Government

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
Fluorodeoxyglucose F18
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014