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

Breast Cancer Clinical Trial

Official title:

Molecular Predictors of Loco-Regional Recurrence in Node Positive Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01420185
• Other study ID #: NSABP B-28 ICSCA
• Secondary ID: NSABP-B28-ICSC-A
• Status: Active, not recruiting
• Phase: N/A
• First received: August 18, 2011
• Last updated: May 6, 2015
• Start date: October 2011

Study information

• Verified date: May 2015
• Source: NSABP Foundation Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1300
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 78 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• RNA analysis

• gene expression analysis

• microarray analysis

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NSABP Foundation Inc	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR		approximately 4 years	No
Primary	Identification of a subgroup of patients who may or may not need radiotherapy after surgery		approximately 4 years	No
Primary	21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients		approximately 4 years	No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database