NCT00362973

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

December 28, 2016

Status Verified

May 1, 2013

Enrollment Period

3.5 years

First QC Date

August 10, 2006

Last Update Submit

December 23, 2016

Conditions

Breast Cancer

Keywords

male breast cancerrecurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (3)

  • Percent change in fludeoxyglucose F 18-positron emission tomography (FDG-PET) standardized uptake value and change in markers of proliferation (Ki67) at 2 weeks

    2 weeks

  • Percent change in cell proliferation correlated with absolute measures of FDG-PET

    2 weeks

  • Correlation of early FDG-PET with response prediction

    6 months

Study Arms (2)

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 analysisProcedure: needle biopsyProcedure: positron emission tomographyProcedure: radionuclide imagingRadiation: 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 analysisProcedure: needle biopsyProcedure: positron emission tomographyProcedure: radionuclide imagingRadiation: fludeoxyglucose F 18

Interventions

laboratory biomarker analysisOTHER
HER-2/neu Positive Breast CancerHormone Receptor Positive Breast Cancer
needle biopsyPROCEDURE
HER-2/neu Positive Breast CancerHormone Receptor Positive Breast Cancer
positron emission tomographyPROCEDURE
HER-2/neu Positive Breast CancerHormone Receptor Positive Breast Cancer
radionuclide imagingPROCEDURE
HER-2/neu Positive Breast CancerHormone Receptor Positive Breast Cancer
fludeoxyglucose F 18RADIATION
HER-2/neu Positive Breast CancerHormone Receptor Positive Breast Cancer

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with primary, recurrent or metastatic breast cancer that is either hormonal receptor positive or HER-2/neu positive.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

Biopsy, NeedleMagnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative TechniquesSpectrum AnalysisChemistry Techniques, AnalyticalDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Hannah M. Linden, MD

    Seattle Cancer Care Alliance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

May 1, 2006

Primary Completion

November 1, 2009

Last Updated

December 28, 2016

Record last verified: 2013-05

Locations

US(2)