Clinical trial · Observational
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
NCT01420185CI-TRIAL-00017855unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gene expression analysis | Genetic | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| microarray analysis | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| RNA analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR
- timeFrame
- approximately 4 years
- measure
- Identification of a subgroup of patients who may or may not need radiotherapy after surgery
- timeFrame
- approximately 4 years
- measure
- 21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients
- timeFrame
- approximately 4 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 78 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWolmark 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. PMID 27217450