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

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00362973

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:	Diagnostic, Open Label
Official Title:	Early Assessment of Response to Targeted Breast Cancer Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nuclear Scans Radiation Therapy

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	40
Study Start Date:	May 2006
Estimated Primary Completion Date:	December 2008 (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
Seattle Cancer Care Alliance	Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824
University of Washington School of Medicine	Recruiting
Seattle, Washington, United States, 98195
Contact: Clinical Trials Office - University of Washington School of Me 206-616-8289

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Hannah M. Linden, MD

Seattle Cancer Care Alliance

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000492255, UWCC-UW-6213, UWCC-06-0445-H/D
Study First Received:	August 10, 2006
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00362973 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms, Male
Trastuzumab
Breast Neoplasms

Breast Cancer, Male
Hormones
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 02, 2009