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
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

ClinicalTrials.gov processed this record on April 15, 2014