Breast CancerNCT00897091
S8814A Biomarkers in Predicting Outcome in Postmenopausal Women With Hormone Receptor-Positive, Node-Positive Breast Cancer Treated With Tamoxifen With or Without Cyclophosphamide, Doxorubicin, and Fluorouracil
An observational study of Breast Cancer, run by SWOG Cancer Research Network at 1 site in United States.
Trial summary
RATIONALE: Studying samples of tumor 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 how patients will respond 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?
- comparative genomic hybridization, microarray analysis and reverse transcriptase-polymerase chain reaction
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Oct 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 consenting to banking in S8814
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Node-positive disease (pT1-3a, pN1-2 [clinical N0-1], M0)
- Previously enrolled in SWOG-8814, a treatment clinical trial, and in SWOG-9445, a companion tissue banking study
- Tumor block or unstained sections available from initial diagnosis in the SWOG archive
- Sufficient tumor in block or unstained sections
- Patients for whom only unstained slides are available must have acceptable reverse-transcriptase-polymerase chain reaction (RT-PCR) profiles
- Sufficient RNA (≥ 300 ng) for RT-PCR analysis with the Oncotype DX 21 gene assay
- Average normalized cycle threshold for the 5 reference genes ≤ 35
- Follow-up data from the SWOG-8814 clinical trial obtained from the patient
- Hormone receptor status:
- Estrogen and/or progesterone receptor positive tumor
PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Molecular Predictors of Outcome on CAF Plus Tamoxifen Versus Tamoxifen Alone in Postmenopausal Women With Node Positive, Receptor Positive Breast Cancer [NCI Correlative Science Reference No. # 8814A-ICSC]
RATIONALE: Studying samples of tumor 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 how patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in predicting outcome in postmenopausal women with hormone receptor-positive, node-positive breast cancer treated with tamoxifen with or without cyclophosphamide, doxorubicin, and fluorouracil.
Read the detailed description
OBJECTIVES:
Primary
- Determine the value of the Oncotype DX Recurrence Score for prediction of treatment benefit of cyclophosphamide, doxorubicin hydrochloride, and fluorouracil (CAF) chemotherapy, in terms of disease-free survival (DFS) and overall survival (OS), in postmenopausal patients with estrogen and/or progesterone receptor-positive, node-positive breast cancer treated on clinical trial SWOG-8814.
- Determine the overall prognostic value of the Oncotype DX Recurrence Score, in terms of DFS and OS, in patients treated with tamoxifen citrate alone or CAF with concurrent or sequential tamoxifen citrate.
Secondary
- Determine the optimal cut point (i.e., low, intermediate, and high recurrence risk) for the Recurrence Score in these patients.
- Determine the relationship between expression of any one of the 21 genes on the Oncotype DX gene panel with DFS and OS.
- Determine whether the expression of any of these genes are associated with CAF treatment benefit.
- Determine the relationship between the Oncotype DX Recurrence Score and DFS and OS in multivariate models, including number of positive nodes, tumor size, tumor grade, estrogen receptor, progesterone receptor, and HER2 and p53 status.
- Determine the relationship between quantitative reverse-transcriptase-polymerase chain reaction expression of up to 800 additional genes and prognosis and/or prediction of CAF benefit.
OUTLINE: This is a multicenter study.
Fixed paraffin-embedded breast tumor tissue samples (obtained from the SWOG Central Tumor Repository at the University of Colorado) are analyzed by the Oncotype DX panel containing the following 21 genes: BAG1, Bc12, CCNB1, CD68, SCUBE2, CTSL2, Esrt1, GRB7, GSTM1, HER2, Ki-67, MYBL2, PR, STK15, STMY3, SURV, B-actin, GAPDH, GUS, RPLPO, and TFRC. The Oncotype DX Recurrence Score is calculated for each patient. Analyses are performed to determine the relationship between the Recurrence Score and gene expression and prognosis/prediction of therapy (tamoxifen citrate alone or cyclophosphamide, doxorubicin hydrochloride, and fluorouracil with concurrent or sequential tamoxifen citrate) benefit as well as to determine the relationship between clinical and demographic covariates and disease-free and overall survival.
Samples are also analyzed by reverse-transcriptase-polymerase chain reaction for exploratory analysis of up to 800 additional genes that may be prognostic and/or predict the likelihood of therapy benefit.
- Conditions
- Breast Cancer
- Being tested
- comparative genomic hybridization, microarray analysis, reverse transcriptase-polymerase chain reaction, diagnostic laboratory biomarker analysis
- Keywords
- stage II breast cancer, stage IIIA 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.
comparative genomic hybridizationGenetic
microarray analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
diagnostic laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Overall survival
Secondary outcomes (1)
Distant disease-free recurrence
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 startJul 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Time perspective
- Retrospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kathy S. Albain, MD, Study chair, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897091
- Sponsor's protocol ID
- CDR0000528264
- Other IDs
- S8814A-ICSC, GHI-01-024, U10CA032102
- Status last verified
- May 2013
- First submitted
- 9 May 2009
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Predictors of Outcome on CAF Plus Tamoxifen Versus Tamoxifen Alone in Postmenopausal Women With Node Positive, Receptor Positive Breast Cancer [NCI Correlative Science Reference No. # 8814A-ICSC]
- ClinicalTrials.gov ID
- NCT00897091
- Acronym / sponsor ID
- CDR0000528264
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 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 tumor 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 how patients will respond to treatment.
PURPOSE: This laboratory study is looking at biomarkers in predicting outcome in postmenopausal women with hormone receptor-positive, node-positive breast cancer treated with tamoxifen with or without cyclophosphamide, doxorubicin, and fluorouracil.
Detailed description
OBJECTIVES:
Primary
- Determine the value of the Oncotype DX Recurrence Score for prediction of treatment benefit of cyclophosphamide, doxorubicin hydrochloride, and fluorouracil (CAF) chemotherapy, in terms of disease-free survival (DFS) and overall survival (OS), in postmenopausal patients with estrogen and/or progesterone receptor-positive, node-positive breast cancer treated on clinical trial SWOG-8814.
- Determine the overall prognostic value of the Oncotype DX Recurrence Score, in terms of DFS and OS, in patients treated with tamoxifen citrate alone or CAF with concurrent or sequential tamoxifen citrate.
Secondary
- Determine the optimal cut point (i.e., low, intermediate, and high recurrence risk) for the Recurrence Score in these patients.
- Determine the relationship between expression of any one of the 21 genes on the Oncotype DX gene panel with DFS and OS.
- Determine whether the expression of any of these genes are associated with CAF treatment benefit.
- Determine the relationship between the Oncotype DX Recurrence Score and DFS and OS in multivariate models, including number of positive nodes, tumor size, tumor grade, estrogen receptor, progesterone receptor, and HER2 and p53 status.
- Determine the relationship between quantitative reverse-transcriptase-polymerase chain reaction expression of up to 800 additional genes and prognosis and/or prediction of CAF benefit.
OUTLINE: This is a multicenter study.
Fixed paraffin-embedded breast tumor tissue samples (obtained from the SWOG Central Tumor Repository at the University of Colorado) are analyzed by the Oncotype DX panel containing the following 21 genes: BAG1, Bc12, CCNB1, CD68, SCUBE2, CTSL2, Esrt1, GRB7, GSTM1, HER2, Ki-67, MYBL2, PR, STK15, STMY3, SURV, B-actin, GAPDH, GUS, RPLPO, and TFRC. The Oncotype DX Recurrence Score is calculated for each patient. Analyses are performed to determine the relationship between the Recurrence Score and gene expression and prognosis/prediction of therapy (tamoxifen citrate alone or cyclophosphamide, doxorubicin hydrochloride, and fluorouracil with concurrent or sequential tamoxifen citrate) benefit as well as to determine the relationship between clinical and demographic covariates and disease-free and overall survival.
Samples are also analyzed by reverse-transcriptase-polymerase chain reaction for exploratory analysis of up to 800 additional genes that may be prognostic and/or predict the likelihood of therapy benefit.
Study design
- 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 consenting to banking in S8814
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 |
|---|---|---|
| comparative genomic hybridization | Genetic | – |
| microarray analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| diagnostic laboratory biomarker analysis | Other | – |
Primary outcome
Disease-free survival
Overall survival
1 secondary outcome
Distant disease-free recurrence
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 30 May 2013.
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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.
Kathy S. Albain, MD study chair
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by SWOG Cancer Research Network at 1 site in United States.
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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Disease-free survival. 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?
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 30 May 2013.