- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967239
Study of Blood Samples From High-Risk Postmenopausal Women Who Received Treatment on Breast Cancer Prevention Clinical Trials NSABP-P-1 or NSABP-P-2
The Pharmacogenomics of Breast Cancer Prevention: A Genome-Wide Association Study in Participants Experiencing Breast Cancer Events in High-Risk Postmenopausal Women Receiving Selective Estrogen Receptor Modulators on NSABP Trials P-1 and P-2
RATIONALE: Studying the genes expressed in samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood samples from high-risk postmenopausal women who received treatment on breast cancer prevention clinical trials NSABP-P-1 or NSABP-P-2.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
Primary
- To identify genes associated with breast events (i.e., the occurrence of invasive breast cancer or ductal carcinoma in situ), in terms of single-nucleotide polymorphisms (SNPs) in a genome-wide association study, in Caucasian women at high risk of developing breast cancer who have received a selective estrogen receptor modulator (SERM) (i.e., tamoxifen or raloxifene) on the NSABP-P-1 OR NSABP-P-2 breast cancer prevention clinical trials.
- To determine the impact of CYP2D6 metabolizer status, which includes genotype and status of concurrent use of CYP2D6 inhibitors, on breast cancer events in participants receiving either tamoxifen or raloxifene.
Secondary
- To explore whether multiple SNPs within a region are independently associated with a breast event.
- To explore whether there are interactions among SNPs that increase the risk for a breast event.
- To explore whether there is interaction of any SNPs identified in the primary objective with randomized treatment, in terms of the risk for a breast event.
- To identify rare variants that might affect estrogen-dependent expression of chromosomes (CTSO) 4 and 16 (ZNF423) and/or the relationship to BRCA1 expression.
OUTLINE: Samples are stratified according to CYP2D6 genotype and CYP2D6 metabolizer status.
DNA extracted from previously collected blood samples is analyzed in a genome-wide association study and compared with 2 control samples from patients who did not experience a breast event. DNA samples are used to identify and analyze single nucleotide polymorphisms.
Also, exploratory analyses are conducted examining the impact of CYP2D6 metabolizer status on breast cancer events according to invasive vs non-invasive disease, ER status, PgR status, histologic type, and TMN stage.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
Meets 1 of the following criteria:
Previously treated on the NSABP-P-1 Breast Cancer Prevention clinical trial
- Caucasian women that did or did not experience an invasive breast cancer or ductal carcinoma in situ (DCIS)
- At least 50 years of age at time of entry to P-1
Previously treated on the NSABP-P-2 Breast Cancer Prevention clinical trial
- Caucasian women that did or did not experience an invasive breast cancer or DCIS
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Postmenopausal status
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of genes, as measured by single-nucleotide polymorphisms (SNPs), that are associated with breast events
Time Frame: Approximately 6 years
|
Retrospective study design: SNPs associated with available breast cancer events
|
Approximately 6 years
|
Impact of CYP2D6 metabolizer status on breast cancer events
Time Frame: Approximately 6 years
|
Retrospective study design: assay results associated with available breast cancer events
|
Approximately 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploration of whether SNPs within a region are independently associated with a breast event
Time Frame: Approximately 6 years
|
Retrospective study design: assay results associated with available breast cancer events
|
Approximately 6 years
|
Exploration of whether interactions among SNPs increase the risk for a breast event
Time Frame: Approximately 6 years
|
Retrospective study design: results associated with available breast cancer events
|
Approximately 6 years
|
Exploration of whether SNPs have an effect on treatment
Time Frame: Approximately 6 years
|
Retrospective study design: SNPs associated with appropriate treatment information
|
Approximately 6 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NSABP MCO831
- NSABP-MC083I
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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