Identification of Genes That Predict Local Recurrence in Samples From Patients With Breast Cancer Treated on NSABP-B-28
|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
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
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: RNA analysis Genetic: gene expression analysis Genetic: microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis|
- 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).
|Study Type :||Observational|
|Estimated Enrollment :||1300 participants|
|Observational Model:||Case Control|
|Official Title:||Molecular Predictors of Loco-Regional Recurrence in Node Positive Breast Cancer|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||December 2015|
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420185
|Principal Investigator:||Terry Mamounas, MD, MPH, FACS||Aultman Cancer Center at Aultman Hospital|