S8814A Biomarkers in Predicting Outcome in Postmenopausal Women With Hormone Receptor-Positive, Node-Positive Breast Cancer Treated With Tamoxifen With or Without Cyclophosphamide, Doxorubicin, and Fluorouracil

NCT00897091 | Completed

• 4 other identifiers: CDR0000528264S8814A-ICSCGHI-01-024U10CA032102
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This laboratory study is looking at biomarkers in predicting outcome in postmenopausal women with hormone receptor-positive, node-positive breast cancer treated with tamoxifen with or without cyclophosphamide, doxorubicin, and fluorouracil.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (2)

• Disease-free survival

• Overall survival

Secondary Outcomes (1)

• Distant disease-free recurrence

Interventions

comparative genomic hybridization GENETIC

microarray analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

diagnostic laboratory biomarker analysis OTHER

Eligibility Criteria

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

Study Population

Patients consenting to banking in S8814

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Node-positive disease (pT1-3a, pN1-2 \[clinical N0-1\], M0) * Previously enrolled in SWOG-8814, a treatment clinical trial, and in SWOG-9445, a companion tissue banking study * Tumor block or unstained sections available from initial diagnosis in the SWOG archive * Sufficient tumor in block or unstained sections * Patients for whom only unstained slides are available must have acceptable reverse-transcriptase-polymerase chain reaction (RT-PCR) profiles * Sufficient RNA (≥ 300 ng) for RT-PCR analysis with the Oncotype DX 21 gene assay * Average normalized cycle threshold for the 5 reference genes ≤ 35 * Follow-up data from the SWOG-8814 clinical trial obtained from the patient * Hormone receptor status: * Estrogen and/or progesterone receptor positive tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal 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

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Comparative Genomic Hybridization; 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)

Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; Microchip Analytical Procedures; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Kathy S. Albain, MD

  Loyola University

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

US (1)