NCT00896623

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment. PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast cancer to see if it can predict treatment outcome.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,577

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

May 9, 2009

Last Update Submit

February 15, 2017

Conditions

Keywords

stage I breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • Differences in outcome according to common variant alleles

    Through study follow-up an average of 10.8 years

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients enrolled to SWOG 8897 consenting to banking

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Node-negative breast cancer * Enrolled on clinical trial SWOG-8897 * Archived tissue from patients with normal lymph nodes in the low-risk group receiving no treatment and those in the intermediate group receiving treatment * Hormone receptor status known PATIENT CHARACTERISTICS: * Female * Pre- or post-menopausal PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff MD, Hortobagyi GN, Hayes DF, Ambrosone CB. Manganese superoxide dismutase polymorphism, treatment-related toxicity and disease-free survival in SWOG 8897 clinical trial for breast cancer. Breast Cancer Res Treat. 2010 Nov;124(2):433-9. doi: 10.1007/s10549-010-0840-0. Epub 2010 Mar 23.

  • Yao S, Barlow WE, Albain KS, Choi JY, Zhao H, Livingston RB, Davis W, Rae JM, Yeh IT, Hutchins LF, Ravdin PM, Martino S, Lyss AP, Osborne CK, Abeloff M, Hortobagyi GN, Hayes DF, Ambrosone CB. Gene polymorphisms in cyclophosphamide metabolism pathway,treatment-related toxicity, and disease-free survival in SWOG 8897 clinical trial for breast cancer. Clin Cancer Res. 2010 Dec 15;16(24):6169-76. doi: 10.1158/1078-0432.CCR-10-0281.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Amplified Fragment Length Polymorphism AnalysisSpectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA FingerprintingGenetic TechniquesInvestigative TechniquesPolymerase Chain ReactionNucleic Acid Amplification TechniquesMass SpectrometryChemistry Techniques, Analytical

Study Officials

  • Christine B. Ambrosone, PhD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

December 1, 2006

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

https://swog.org/Visitors/Download/Policies/Policy43.pdf