- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01420185
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
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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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).
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR
Tidsram: approximately 4 years
|
approximately 4 years
|
Identification of a subgroup of patients who may or may not need radiotherapy after surgery
Tidsram: approximately 4 years
|
approximately 4 years
|
21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients
Tidsram: approximately 4 years
|
approximately 4 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Terry Mamounas, MD, MPH, FACS, Aultman Cancer Center at Aultman Hospital
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NSABP B-28 ICSCA
- NSABP-B28-ICSC-A
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