Breast CancerNCT00896623
SWOG 8897-A DNA Analysis in Predicting Treatment Outcome in Women With Breast Cancer in SWOG 8897
An observational study of Breast Cancer, run by SWOG Cancer Research Network.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- mutation analysis, polymorphism analysis and surface-enhanced laser desorption/ionization-time of flight mass spectrometry
- How many people
- 1,577 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 2007
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897
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.
Read the detailed description
OBJECTIVES:
- Determine if polymorphisms resulting in greater activation of cyclophosphamide (CYP2B6, CYP3A4, and CYP3A5) are associated with disease-free survival and treatment toxicities in women with breast cancer.
- Determine if polymorphisms resulting in less production of quinone-related oxidative damage of doxorubicin hydrochloride (NQO1, NQO2, NOS2, NOS3, CBR3) are associated with disease-free survival and treatment toxicities in these patients.
OUTLINE: This is a multicenter study.
Tissue samples archived on clinical trial SWOG-8897 are genotyped for polymorphisms in the CYP3A4, CYP3A5, CYP2B6, NQO1, NQO2, NOS2, NOS3, and CBR3 genes by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry. Variant alleles are correlated with patient outcome.
PROJECTED ACCRUAL: A total of 1,577 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- mutation analysis, polymorphism analysis, surface-enhanced laser desorption/ionization-time of flight mass spectrometry
- Keywords
- stage I breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation analysisGenetic
polymorphism analysisGenetic
surface-enhanced laser desorption/ionization-time of flight mass spectrometryOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in outcome according to common variant alleles
Measured: Through study follow-up an average of 10.8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startDec 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,577 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christine B. Ambrosone, PhD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896623
- Sponsor's protocol ID
- CDR0000529126
- Other IDs
- SWOG-8897-ICSC
- Status last verified
- Feb 2017
- First submitted
- 9 May 2009
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://swog.org/Visitors/Download/Policies/Policy43.pdf
Publications
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.
PubMed 20309628Yao 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.
PubMed 21169260
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics in Relation to Breast Cancer Outcomes in SWOG 8897
- ClinicalTrials.gov ID
- NCT00896623
- Acronym / sponsor ID
- CDR0000529126
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,577 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 12 May 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 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.
Detailed description
OBJECTIVES:
- Determine if polymorphisms resulting in greater activation of cyclophosphamide (CYP2B6, CYP3A4, and CYP3A5) are associated with disease-free survival and treatment toxicities in women with breast cancer.
- Determine if polymorphisms resulting in less production of quinone-related oxidative damage of doxorubicin hydrochloride (NQO1, NQO2, NOS2, NOS3, CBR3) are associated with disease-free survival and treatment toxicities in these patients.
OUTLINE: This is a multicenter study.
Tissue samples archived on clinical trial SWOG-8897 are genotyped for polymorphisms in the CYP3A4, CYP3A5, CYP2B6, NQO1, NQO2, NOS2, NOS3, and CBR3 genes by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry. Variant alleles are correlated with patient outcome.
PROJECTED ACCRUAL: A total of 1,577 patients will be accrued for this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients enrolled to SWOG 8897 consenting to banking
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 |
|---|---|---|
| mutation analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| surface-enhanced laser desorption/ionization-time of flight mass spectrometry | Other | – |
Primary outcome
Differences in outcome according to common variant alleles
Time frame: Through study follow-up an average of 10.8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Results publication: PubMed 20309628Yao 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.
- Results publication: PubMed 21169260Yao 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.
- Individual participant dataSharing planned: Yes. https://swog.org/Visitors/Download/Policies/Policy43.pdf
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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.
Christine B. Ambrosone, PhD study chair
Roswell Park Cancer Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by SWOG Cancer Research Network.
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: finished, as of the sponsor's last update on 17 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in outcome according to common variant alleles (time frame: Through study follow-up an average of 10.8 years). 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 NCT00896623, which also lists 2 linked publications.
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 17 Feb 2017.