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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT00967239
First received: August 26, 2009
Last updated: May 6, 2015
Last verified: May 2015
  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
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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 NSABP Foundation Inc:

Primary Outcome Measures:
  • Identification of genes, as measured by single-nucleotide polymorphisms (SNPs), that are associated with breast events [ Time Frame: Approximately 6 years ] [ Designated as safety issue: No ]
    Retrospective study design: SNPs associated with available breast cancer events

  • Impact of CYP2D6 metabolizer status on breast cancer events [ Time Frame: Approximately 6 years ] [ Designated as safety issue: No ]
    Retrospective study design: assay results associated with available breast cancer events


Secondary Outcome Measures:
  • Exploration of whether SNPs within a region are independently associated with a breast event [ Time Frame: Approximately 6 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Retrospective study design: results associated with available breast cancer events

  • Exploration of whether SNPs have an effect on treatment [ Time Frame: Approximately 6 years ] [ Designated as safety issue: No ]
    Retrospective study design: SNPs associated with appropriate treatment information


Biospecimen Retention:   None Retained

DNA extracted from stored lymphocytes


Estimated Enrollment: 1881
Study Start Date: April 2009
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967239

Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Study Chair: James N. Ingle, MD Mayo Clinic
  More Information

Additional Information:
No publications provided by NSABP Foundation Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00967239     History of Changes
Other Study ID Numbers: NSABP MCO831, NSABP-MC083I
Study First Received: August 26, 2009
Last Updated: May 6, 2015
Health Authority: United States: Federal Government

Keywords provided by NSABP Foundation Inc:
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Estrogen Receptor Modulators
Selective Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 03, 2015