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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

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ClinicalTrials.gov Identifier: NCT00967239
Recruitment Status : Unknown
Verified May 2015 by NSABP Foundation Inc.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2009
Last Update Posted : May 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

Tracking Information
First Submitted Date August 26, 2009
First Posted Date August 27, 2009
Last Update Posted Date May 8, 2015
Study Start Date April 2009
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 6, 2015)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: August 26, 2009)
  • Identification of genes, as measured by SNPs, that are associated with breast events
  • Impact of CYP2D6 metabolizer status on breast cancer events
Change History Complete list of historical versions of study NCT00967239 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 6, 2015)
  • 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
  • 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
  • Exploration of whether SNPs have an effect on treatment [ Time Frame: Approximately 6 years ]
    Retrospective study design: SNPs associated with appropriate treatment information
Original Secondary Outcome Measures
 (submitted: August 26, 2009)
  • Exploration of whether SNPs within a region are independently associated with a breast event
  • Exploration of whether interactions among SNPs increase the risk for a breast event
  • Exploration of whether SNPs have an effect on treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.

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 Observational
Study Design Observational Model: Case Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
DNA extracted from stored lymphocytes
Sampling Method Non-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)
Condition Breast Cancer
Intervention
  • Genetic: DNA analysis
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
  • Other: pharmacogenomic studies
Study Groups/Cohorts Not Provided
Publications * 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. Erratum in: Clin Cancer Res. 2012 Jun 15;18(12):3491.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 26, 2009)
1881
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00967239
Other Study ID Numbers NSABP MCO831
NSABP-MC083I
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NSABP Foundation Inc
Study Sponsor NSABP Foundation Inc
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: James N. Ingle, MD Mayo Clinic
PRS Account NSABP Foundation Inc
Verification Date May 2015