NCT00967239

Brief Summary

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.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
1,881

participants targeted

Target at P75+ for all trials

Status
unknown

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

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

6.7 years

First QC Date

August 26, 2009

Last Update Submit

May 6, 2015

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situinvasive ductal breast carcinomainvasive lobular breast carcinomainvasive lobular breast carcinoma with predominant in situ component

Outcome Measures

Primary Outcomes (2)

  • Identification of genes, as measured by single-nucleotide polymorphisms (SNPs), that are associated with breast events

    Retrospective study design: SNPs associated with available breast cancer events

    Approximately 6 years

  • Impact of CYP2D6 metabolizer status on breast cancer events

    Retrospective study design: assay results associated with available breast cancer events

    Approximately 6 years

Secondary Outcomes (3)

  • Exploration of whether SNPs within a region are independently associated with a breast event

    Approximately 6 years

  • Exploration of whether interactions among SNPs increase the risk for a breast event

    Approximately 6 years

  • Exploration of whether SNPs have an effect on treatment

    Approximately 6 years

Interventions

DNA analysisGENETIC
polymorphism analysisGENETIC
laboratory biomarker analysisOTHER
pharmacogenomic studiesOTHER

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

breast cancer cases and matched controls from: participants in NSABP P-1 (tamoxifen or no tamoxifen) participants in NSABP P-2 (raloxifene or no raloxifene; tamoxifen or no tamoxifen)

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

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

Sponsors & Collaborators

Related Publications (1)

  • Goetz MP, Schaid DJ, Wickerham DL, Safgren S, Mushiroda T, Kubo M, Batzler A, Costantino JP, Vogel VG, Paik S, Carlson EE, Flockhart DA, Wolmark N, Nakamura Y, Weinshilboum RM, Ingle JN, Ames MM. Evaluation of CYP2D6 and efficacy of tamoxifen and raloxifene in women treated for breast cancer chemoprevention: results from the NSABP P1 and P2 clinical trials. Clin Cancer Res. 2011 Nov 1;17(21):6944-51. doi: 10.1158/1078-0432.CCR-11-0860. Epub 2011 Aug 31.

    PMID: 21880792DERIVED

Biospecimen

Retention: NONE RETAINED

DNA extracted from stored lymphocytes

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingCarcinoma, Ductal, BreastCarcinoma, Lobular

Interventions

Amplified Fragment Length Polymorphism AnalysisPharmacogenomic Testing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, Ductal

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesGenetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • James N. Ingle, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2015

Last Updated

May 8, 2015

Record last verified: 2015-05