FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
NCT01928186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2018-05-15
Summary
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.
Conditions
- Estrogen Receptor Positive
- HER2/Neu Negative
- Male Breast Carcinoma
- Stage IA Breast Cancer
- Stage IB Breast Cancer
- Stage IIA Breast Cancer
- Stage IIB Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
Interventions
- DRUG
-
Fluorothymidine F-18
Undergo FLT PET
- PROCEDURE
-
Positron Emission Tomography
Undergo FLT PET
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Run-in (short pre-surgery course) of endocrine-targeted therapy
Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Hannah Linden · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-09-30
- Primary Completion
- 2015-07-20
- Completion
- 2015-07-20
Countries
- United States
Study Locations
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