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Identification of Genes That Predict Local Recurrence in Samples From Patients With Breast Cancer Treated on NSABP-B-28

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ClinicalTrials.gov Identifier: NCT01420185
Recruitment Status : Unknown
Verified May 2015 by NSABP Foundation Inc.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2011
Last Update Posted : May 8, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NSABP Foundation Inc

August 18, 2011
August 19, 2011
May 8, 2015
October 2011
December 2015   (Final data collection date for primary outcome measure)
  • Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR [ Time Frame: approximately 4 years ]
  • Identification of a subgroup of patients who may or may not need radiotherapy after surgery [ Time Frame: approximately 4 years ]
  • 21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients [ Time Frame: approximately 4 years ]
  • Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR
  • Identification of a subgroup of patients who may or may not need radiotherapy after surgery
  • 21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients
Complete list of historical versions of study NCT01420185 on ClinicalTrials.gov Archive Site
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Identification of Genes That Predict Local Recurrence in Samples From Patients With Breast Cancer Treated on NSABP-B-28
Molecular Predictors of Loco-Regional Recurrence in Node Positive Breast Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict whether cancer will come back after treatment.

PURPOSE: This research trial is studying genes that may predict local recurrence in samples from patients with breast cancer. treated on NSABP-B-28

OBJECTIVES:

  • To evaluate the association between the 21-gene Recurrence Score and risk of local-regional recurrence (LRR) in node-positive, estrogen receptor- (ER) positive (+) patients treated with cyclophosphamide and doxorubicin hydrochloride (AC) with or without paclitaxel in the NSABP-B-28 trial.
  • To evaluate the potential for combining the 21-gene Recurrence Score (RS) with traditional clinico-pathologic factors in order to derive an improved algorithm for prediction of LRR risk and in order to identify subgroups of ER-positive patients with 1-3 or 4 or more positive nodes who do/do not need post mastectomy chest wall radiotherapy (XRT) or regional nodal XRT (irrespective of surgical procedure).
  • To evaluate whether the 21-gene RS predicts benefit from adding paclitaxel to AC chemotherapy in reducing risk of LRR, and improving disease-free survival (DFS) and overall survival (OS) in node-positive, ER-positive patients from NSABP-B-28.

OUTLINE: RNA extracted from paraffin-embedded tissue samples are analyzed for gene expression profile by Ribogreen assay and RT-PCR. Results are then compared and analyzed with each patient clinical-pathologic factors, including tumor size, patient age, number of positive nodes (1-3, 4+), tumor grade, and surgery type (mastectomy or lumpectomy).

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Non-Probability Sample
Stored tissue from participants in protocol NSABP B-28.
Breast Cancer
  • Genetic: RNA analysis
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1300
Same as current
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December 2015   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosed with breast cancer and enrolled on NSABP-B-28.

    • Estrogen-receptor positive (ER+)
    • Node-positive disease
  • Primary tumor tissue samples available
  • Treated with cyclophosphamide and doxorubicin hydrochloride and tamoxifen with or without paclitaxel

PATIENT CHARACTERISTICS:

  • Menopausal status not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Sexes Eligible for Study: Female
18 Years to 78 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01420185
NSABP B-28 ICSCA
NSABP-B28-ICSC-A
No
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NSABP Foundation Inc
NSABP Foundation Inc
National Cancer Institute (NCI)
Principal Investigator: Terry Mamounas, MD, MPH, FACS Aultman Cancer Center at Aultman Hospital
NSABP Foundation Inc
May 2015