Breast CancerNCT00897299
Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy
An observational study of Breast Cancer and Estrogen Receptor, run by Eastern Cooperative Oncology Group.
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 whether cancer will come back after treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Estrogen Receptor, Her-2
- What is being tested?
- microarray analysis, protein expression analysis and immunohistochemistry staining method
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 7 Oct 2005to 8 Oct 2005
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Node positive OR high-risk node negative disease
- Tumor > 1.0 cm in diameter
- No locally advanced, inflammatory, or metastatic breast cancer
- Previously treated with 4 courses of anthracycline-containing chemotherapy (i.e., doxorubicin and docetaxel OR doxorubicin and cyclophosphamide)
- Enrolled on clinical trial ECOG-E2197
- Adequate tumor material available in ECOG Pathology Coordination Center
- Previously consented to future cancer-related research
- Hormone receptor status known
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
About this study
Official title: Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy
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 whether cancer will come back after treatment.
PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.
Read the detailed description
OBJECTIVES:
- Assess the prognostic utility of the Oncotype DX™ 21 gene profile for risk of relapse in women with node positive or high-risk node negative breast cancer.
- Identify individual genes whose RNA expression is associated with an increased risk of relapse in these patients.
- Perform an exploratory analysis of individual genes whose RNA expression is associated with an increased risk of relapse differentially in patients previously treated with docetaxel.
OUTLINE: This is a multicenter study.
Tissue samples are examined for association of RNA expression and clinical factors (e.g., tumor size, nodal status, hormone receptor status, age, menopause status), as well as estrogen receptor, progesterone receptor, and HER-2/neu expression by immunohistochemistry and other studies.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.
- Conditions
- Breast Cancer, Estrogen Receptor, Her-2, Pgr
- Being tested
- microarray analysis, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- estrogen receptor, HER-2, PgR, stage II breast cancer, stage IIIA breast cancer, stage IIIB 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.
microarray analysisGenetic
protein expression analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Distant, local/regional, and ipsilateral breast relapse
First breast cancer recurrence
Relapse-free interval
Secondary outcomes (3)
Distant involvement at time of first recurrence
Disease-free survival
Overall survival
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 start7 Oct 2005
- Primary completion8 Oct 2005
- Study completion8 Oct 2005
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.
- 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
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Joseph A. Sparano, MD, Study chair, Albert Einstein College of MedicineLori J. Goldstein, MD, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897299
- Sponsor's protocol ID
- CDR0000456426
- Other IDs
- ECOG-E21971CSC, NCI-7613, SANOFI-AVENTIS-ECOG-E21971CSC, GENOMIC-ECOG-E21971CSC
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Badve SS, Baehner FL, Gray R, et al.: ER and PR assessment in ECOG 2197: comparison of locally determined IHC with centrally determined IHC and quantitative RT-PCR. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-87, 2007.
Sparano JA, Goldstein L, Childs B, et al.: Association of individual genes with risk of relapse in operable breast cancer: analysis of E2197. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-27, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Genomic Predictors of Recurrence After Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT00897299
- Acronym / sponsor ID
- CDR0000456426
- Conditions
- Breast Cancer, Estrogen Receptor, Her-2, Pgr
- Keywords
- estrogen receptor, HER-2, PgR, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Oct 2005 (actual)
- Primary completion
- 8 Oct 2005 (actual)
- Study completion
- 8 Oct 2005 (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 whether cancer will come back after treatment.
PURPOSE: This laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.
Detailed description
OBJECTIVES:
- Assess the prognostic utility of the Oncotype DX™ 21 gene profile for risk of relapse in women with node positive or high-risk node negative breast cancer.
- Identify individual genes whose RNA expression is associated with an increased risk of relapse in these patients.
- Perform an exploratory analysis of individual genes whose RNA expression is associated with an increased risk of relapse differentially in patients previously treated with docetaxel.
OUTLINE: This is a multicenter study.
Tissue samples are examined for association of RNA expression and clinical factors (e.g., tumor size, nodal status, hormone receptor status, age, menopause status), as well as estrogen receptor, progesterone receptor, and HER-2/neu expression by immunohistochemistry and other studies.
PROJECTED ACCRUAL: A total of 900 patients will be accrued for this study.
Study design
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| microarray analysis | Genetic | – |
| protein expression analysis | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Distant, local/regional, and ipsilateral breast relapse
First breast cancer recurrence
Relapse-free interval
3 secondary outcomes
Distant involvement at time of first recurrence
Disease-free survival
Overall survival
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 May 2017.
- Results publicationBadve SS, Baehner FL, Gray R, et al.: ER and PR assessment in ECOG 2197: comparison of locally determined IHC with centrally determined IHC and quantitative RT-PCR. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-87, 2007.
- Results publicationSparano JA, Goldstein L, Childs B, et al.: Association of individual genes with risk of relapse in operable breast cancer: analysis of E2197. [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-27, 2007.
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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.
Joseph A. Sparano, MD study chair
Albert Einstein College of Medicine
Lori J. Goldstein, MD
Fox Chase Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Estrogen Receptor, run by Eastern Cooperative Oncology Group.
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 May 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?
Distant, local/regional, and ipsilateral breast relapse. The study lists 3 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 NCT00897299, 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 May 2017.