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 recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
National Surgical Adjuvant Breast and Bowel Project (NSABP)
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00967239
First received: August 26, 2009
Last updated: September 29, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Genetic: DNA analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: pharmacogenomic studies |
| Study Type: | Observational |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Identification of genes, as measured by single-nucleotide polymorphisms (SNPs), that are associated with breast events [ Designated as safety issue: No ]
- Impact of CYP2D6 metabolizer status on breast cancer events [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Exploration of whether SNPs within a region are independently associated with a breast event [ Designated as safety issue: No ]
- Exploration of whether interactions among SNPs increase the risk for a breast event [ Designated as safety issue: No ]
- Exploration of whether SNPs have an effect on treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 1881 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
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.
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.
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00967239 History of Changes |
| Other Study ID Numbers: | CDR0000638644, NSABP-MC083I |
| Study First Received: | August 26, 2009 |
| Last Updated: | September 29, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
ductal breast carcinoma in situ invasive ductal breast carcinoma invasive lobular breast carcinoma invasive lobular breast carcinoma with predominant in situ component |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Selective Estrogen Receptor Modulators |
Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013