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

NCT01420185 | Unknown

• 2 other identifiers: NSABP B-28 ICSCANSABP-B28-ICSC-A
• Study Type: observational
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Breast Cancer

Keywords

estrogen receptor-positive breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (3)

• Association between low, intermediate, and high 21-gene recurrence score (RS) and risk of LRR

  approximately 4 years

• Identification of a subgroup of patients who may or may not need radiotherapy after surgery

  approximately 4 years

• 21-gene RS in predicting treatment benefit, reducing LRR risk, and improving DFS and OS in node-positive ER+ patients

  approximately 4 years

Interventions

RNA analysis GENETIC

gene expression analysis GENETIC

microarray analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stored tissue from participants in protocol NSABP B-28.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NSABP Foundation Inc: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Wolmark 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gene Expression Profiling; Microarray Analysis; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Terry Mamounas, MD, MPH, FACS

  Aultman Cancer Center at Aultman Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 19, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2015
• Last Updated: May 8, 2015

Record last verified: 2015-05