Identification of Genes That Predict Local Recurrence in Samples From Patients With Breast Cancer Treated on NSABP-B-28
NCT ID: NCT01420185
Last Updated: 2015-05-08
Study Results
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Basic Information
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UNKNOWN
1300 participants
OBSERVATIONAL
2011-10-31
Brief Summary
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PURPOSE: This research trial is studying genes that may predict local recurrence in samples from patients with breast cancer. treated on NSABP-B-28
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Detailed Description
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* 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).
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Interventions
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RNA analysis
gene expression analysis
microarray analysis
reverse transcriptase-polymerase chain reaction
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
78 Years
FEMALE
No
Sponsors
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NSABP Foundation Inc
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Terry Mamounas, MD, MPH, FACS
Role: PRINCIPAL_INVESTIGATOR
Aultman Cancer Center at Aultman Hospital
References
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Wolmark N, Mamounas EP, Baehner FL, Butler SM, Tang G, Jamshidian F, Sing AP, Shak S, Paik S. Prognostic Impact of the Combination of Recurrence Score and Quantitative Estrogen Receptor Expression (ESR1) on Predicting Late Distant Recurrence Risk in Estrogen Receptor-Positive Breast Cancer After 5 Years of Tamoxifen: Results From NRG Oncology/National Surgical Adjuvant Breast and Bowel Project B-28 and B-14. J Clin Oncol. 2016 Jul 10;34(20):2350-8. doi: 10.1200/JCO.2015.62.6630. Epub 2016 May 23.
Other Identifiers
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NSABP-B28-ICSC-A
Identifier Type: -
Identifier Source: secondary_id
NSABP B-28 ICSCA
Identifier Type: -
Identifier Source: org_study_id
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