CClinicalTrials.gg
CompletedNCT00897299Updated May 17, 2017

Identifying Genes That Predict Recurrence in Women With Breast Cancer Treated With Chemotherapy

An observational study in Breast Cancer, Estrogen Receptor and Her-2, sponsored by Eastern Cooperative Oncology Group. Completed. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-05-17.

Sponsored by Eastern Cooperative Oncology Group · Observational

Study type
Observational
Enrollment
900
Ages
18 Years to 120 Years
Sex
Female
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Study 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.

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.

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Conditions studied

  • 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
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 900 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
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Study design

Enrollment
900 participants (estimated)

Interventions

  • Geneticmicroarray analysis
  • Geneticprotein expression analysis
  • Otherimmunohistochemistry staining method
  • Otherlaboratory biomarker analysis
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What researchers measure

Primary outcomes

  1. Distant, local/regional, and ipsilateral breast relapse

  2. First breast cancer recurrence

  3. Relapse-free interval

Secondary outcomes

  1. Distant involvement at time of first recurrence

  2. Disease-free survival

  3. Overall survival

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Study locations

No study locations are listed for this record.

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References and documents

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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00897299
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
First posted
May 12, 2009
Start date
Oct 7, 2005
Primary completion
Oct 8, 2005
Completion
Oct 8, 2005
Last update
May 17, 2017

Study contacts

Joseph A. Sparano, MD
study chair · Albert Einstein College of Medicine
Lori J. Goldstein, MD
Fox Chase Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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