Breast CancerNCT00967239
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
An observational study of Breast Cancer, run by NSABP Foundation Inc.
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. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DNA analysis, polymorphism analysis and laboratory biomarker analysis
- How many people
- 1,881 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- DNA analysis, polymorphism analysis, laboratory biomarker analysis, pharmacogenomic studies
- Keywords
- ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, invasive lobular breast carcinoma with predominant in situ component
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
pharmacogenomic studiesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 6 years
Impact of CYP2D6 metabolizer status on breast cancer events
Retrospective study design: assay results associated with available breast cancer events
Measured: Approximately 6 years
Secondary outcomes (3)
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
Measured: Approximately 6 years
Exploration of whether interactions among SNPs increase the risk for a breast event
Retrospective study design: results associated with available breast cancer events
Measured: Approximately 6 years
Exploration of whether SNPs have an effect on treatment
Retrospective study design: SNPs associated with appropriate treatment information
Measured: Approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,881 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- James N. Ingle, MD, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967239
- Sponsor's protocol ID
- NSABP MCO831
- Other IDs
- NSABP-MC083I
- Status last verified
- May 2015
- First submitted
- 26 Aug 2009
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21880792
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00967239
- Acronym / sponsor ID
- NSABP MCO831
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, invasive lobular breast carcinoma with predominant in situ component
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,881 participants (estimated)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2009
- Primary completion
- Dec 2015 (estimated)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| pharmacogenomic studies | Other | – |
Primary outcome
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
3 secondary outcomes
Exploration of whether SNPs within a region are independently associated with a breast event
Time frame: Approximately 6 years
Exploration of whether interactions among SNPs increase the risk for a breast event
Time frame: Approximately 6 years
Exploration of whether SNPs have an effect on treatment
Time frame: Approximately 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Derived from this study: PubMed 21880792Goetz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James N. Ingle, MD study chair
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by NSABP Foundation Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of genes, as measured by single-nucleotide polymorphisms (SNPs), that are associated with breast events (time frame: Approximately 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00967239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.