This trial is active, not recruiting.

Condition breast cancer
Treatments rna analysis, gene expression analysis, microarray analysis, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
Sponsor NSABP Foundation Inc
Collaborator National Cancer Institute (NCI)
Start date October 2011
End date December 2015
Trial size 1300 participants
Trial identifier NCT01420185, NSABP B-28 ICSCA, NSABP-B28-ICSC-A


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective

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

Eligibility Criteria

Female participants from 18 years up to 78 years old.

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

Additional Information

Official title Molecular Predictors of Loco-Regional Recurrence in Node Positive Breast Cancer
Principal investigator Terry Mamounas, MD, MPH, FACS
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by NSABP Foundation Inc.
Location data was received from the National Cancer Institute and was last updated in June 2016.