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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00967239
• Other study ID #: NSABP MCO831
• Secondary ID: NSABP-MC083I
• Status: Active, not recruiting
• Phase: N/A
• First received: August 26, 2009
• Last updated: May 6, 2015
• Start date: April 2009

Study information

• Verified date: May 2015
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1881
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• DNA analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

• pharmacogenomic studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NSABP Foundation Inc	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Impact of CYP2D6 metabolizer status on breast cancer events	Retrospective study design: assay results associated with available breast cancer events	Approximately 6 years	No
Secondary	Exploration of whether SNPs within a region are independently associated with a breast event	Retrospective study design: assay results associated with available breast cancer events	Approximately 6 years	No
Secondary	Exploration of whether interactions among SNPs increase the risk for a breast event	Retrospective study design: results associated with available breast cancer events	Approximately 6 years	No
Secondary	Exploration of whether SNPs have an effect on treatment	Retrospective study design: SNPs associated with appropriate treatment information	Approximately 6 years	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database