Clinical trial · Observational
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 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DNA analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| polymorphism analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Identification of genes, as measured by single-nucleotide polymorphisms (SNPs), that are associated with breast events
- timeFrame
- Approximately 6 years
- description
- Retrospective study design: SNPs associated with available breast cancer events
- measure
- Impact of CYP2D6 metabolizer status on breast cancer events
- timeFrame
- Approximately 6 years
- description
- Retrospective study design: assay results associated with available breast cancer events
Secondary outcomes (3)
- measure
- Exploration of whether SNPs within a region are independently associated with a breast event
- timeFrame
- Approximately 6 years
- description
- Retrospective study design: assay results associated with available breast cancer events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (1)
- DERIVEDGoetz 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. PMID 21880792