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
Sponsor:
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
  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)
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.

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
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 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 September 22, 2014