Trial record 20 of 1773 for:    Open Studies | "Breast Neoplasms"

FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01928186
First received: August 20, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage I-III breast cancer. Comparing results of diagnostic procedures done before and during hormone therapy may help doctors predict a patient's response to treatment and help plan the best treatment.


Condition Intervention
Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Male Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Drug: fluorine F 18 fluorothymidine
Procedure: positron emission tomography
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging Early Response of ER+, HER2- Breast Cancer To Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy With [18F]Fluorothymidine (FLT) PET

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Percent change in net influx constant (Ki) and standard uptake value (SUV) by FLT PET [ Time Frame: Baseline to up to 6 weeks ] [ Designated as safety issue: No ]
    Percent change between pre-treatment and post-therapy measurements will be computed. Log transformations will be considered if the rates of change are highly skewed. Additionally, change in PET measures will be analyzed descriptively (such as by stem-and-leaf plot). Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.

  • Ki-67 percent staining in surgical tissue sample [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Percentage change in Ki-67 [ Time Frame: Baseline to up to 6 weeks ] [ Designated as safety issue: No ]
    Association between Ki-67 and KFLT decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.


Secondary Outcome Measures:
  • Percentage change in K1 by FLT PET [ Time Frame: Baseline to up to 6 weeks ] [ Designated as safety issue: No ]
  • Ki, FLT transport (K1), and SUV values [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Ki, K1, and SUV values [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Gene expression levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.

  • Gene expression levels [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Analyzed using BeadStudio software. Four clustering metrics for calculating dissimilarities (correlation, absolute correlation, Euclidean, and Manhattan) are available in BeadStudio and will be applied using standard analysis methods and diagnostics in BioConductor. To focus the analysis, proposed gene sets will be examined based on biological pathways and molecular signatures.


Estimated Enrollment: 40
Study Start Date: September 2011
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (FLT PET)
Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.
Drug: fluorine F 18 fluorothymidine
Undergo FLT PET
Other Names:
  • 18F-FLT
  • 3'-deoxy-3'-[18F]fluorothymidine
  • fluorothymidine F-18
Procedure: positron emission tomography
Undergo FLT PET
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Measure the effect of a short course of endocrine therapy on primary breast cancer metabolism and proliferation by measuring changes in serial FLT PET measures pre and post a short course of endocrine therapy.

SECONDARY OBJECTIVES:

I. Compare changes in imaging measures to tissue measures of response, in particular antigen identified by proliferation-related Ki-67 antigen (Ki-67), in the pre-therapy biopsy versus the post-therapy surgical specimen.

II. Correlate imaging measures to measures of gene expression from pre and post therapy assays to determine if there are molecular changes associated with early response to therapy.

OUTLINE:

Patients undergo FLT PET at baseline and 1-6 weeks after the start of treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A new diagnosis of invasive breast cancer > 1.0 cm in size, ER+ clinical stage I-III
  • Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study
  • Have tissue block available from core biopsy for correlative biomarkers and genomic assay
  • Have menopausal status determined prior to study enrollment; for study purposes, postmenopausal is defined as

    • A prior documented bilateral oophorectomy, or
    • A history of at least 12 months without spontaneous menstrual bleeding, or
    • Age 60 or older with a prior hysterectomy without oophorectomy, or
    • Age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown) with a documented follicle-stimulating hormone (FSH) level demonstrating confirmatory elevation in the postmenopausal range for the lab
  • Negative pregnancy test within 7 days of baseline positron emission tomography (PET) scan for pre-menopausal patients
  • Tumor HER2/neu expression must be determined (as part of standard clinical care) prior to study enrollment; HER2 may be tested by any Food and Drug Administration (FDA) approved HER2 testing method; if determination is intermediate by immunohistochemistry (IHC), fluorescent in situ hybridization (FISH) or another alternate HER2 test must be performed
  • Be a candidate for [18F]FLT PET imaging
  • Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific screening procedures
  • Be willing and able to comply with scheduled visits and other trial procedures

Exclusion Criteria:

  • Current use of aromatase inhibitor as prevention or treatment for breast cancer
  • Life expectancy of less than two months
  • HER2/neu positive by IHC and/or another FDA approved HER2 testing method
  • Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
  • Weight exceeding capacity of imaging table
  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: NCT01928186

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Hannah M. Linden    206-288-6710      
Principal Investigator: Hannah M. Linden         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Hannah Linden Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01928186     History of Changes
Other Study ID Numbers: 7536, NCI-2013-01380, P30CA015704, RC1CA146456
Study First Received: August 20, 2013
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014