Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer
NCT ID: NCT00899197
Last Updated: 2017-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2007-05-31
2012-06-30
Brief Summary
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PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.
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Detailed Description
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* Identify women who are resistant to tamoxifen citrate and other drugs for the treatment of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage migration inhibition factor) encoded by resistance-inducing genes (RIGs).
* Provide retrospective data on the predictive value of RIGs to serve as the basis for a prospective clinical trial of these genes as predictors of drug resistance.
OUTLINE: This is a multicenter study. Patients are stratified according to response during tamoxifen citrate (TAM) therapy (resistant group \[i.e., those who develop recurrent breast cancer while being treated with TAM\] vs conditionally sensitive group \[i.e., those who have disease-free survival for over 3 years after initial diagnosis while being treated with TAM\]).
Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy, and then every 6 months for 3 years or until relapse, whichever comes first. Samples are analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e., kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional blood sample is obtained from patients at the time of relapse, if available.
Patients also undergo assessment of medical history, personal habits, and characteristics of breast cancer (e.g., tumor histology, stage, and grade) at baseline.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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tamoxifen citrate
gene expression analysis
protein expression analysis
immunoenzyme technique
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Initial pathologic stage I-IIIB disease
* No stage IV disease
* Meets the following criteria for breast cancer therapy:
* Received prior primary local therapy for breast cancer
* Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer within 3 weeks
* Hormone receptor status:
* Estrogen-receptor positive tumor
* Female
* Pre- or post-menopausal
* Must be able to donate 20 mL of blood
Exclusion Criteria
* Psychiatric history that would preclude obtaining informed consent
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Steven A. Akman, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU-74B07
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-IRB00002657
Identifier Type: -
Identifier Source: secondary_id
CDR0000547204
Identifier Type: -
Identifier Source: org_study_id
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