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

N/AUnknownNCT01420185

NSABP Foundation Inc1,300 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,300

Conditions

Breast Cancer

Interventions

RNA analysisGENETIC

gene expression analysisGENETIC

microarray analysisGENETIC

reverse transcriptase-polymerase chain reactionGENETIC

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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