Gene Expression Profiling and Genetic Analysis of Tissues From Patients With Breast Cancer

NCT00899509 | Completed

• 2 other identifiers: CALGB-159905CDR0000285697
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 3

Brief Summary

This research trial studies deoxyribonucleic acid (DNA) in tumor tissue from women with node-positive breast cancer to see if genetic factors are related to the patient's response to chemotherapy. DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment with certain chemotherapy drugs.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Up to 10 years

Secondary Outcomes (1)

• Overall survival

  Up to 10 years

Interventions

laboratory biomarker analysis OTHER

correlative studies

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer enrolled on Cancer and Leukemia Group B (CALGB) 9344 or 9741.

1. Registration to CALGB 9344 or 9741 2. Samples collected, shipped and stored appropriately at the CALGB Pathology Coordinating Office 3. Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required. 4. Informed consent: The CALGB does not require that a separate consent form be signed for this study. * The subject population to be studied in this protocol includes patients selected from one or more of the following CALGB treatment protocols: CALGB 9344 and 9741. * All patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into those trials. * All samples to be studied were obtained and stored as part of the patient's respective treatment trial. The data obtained from the patient's record will be used to obtain appropriate clinical information. In no instance will the patient be contacted directly. * There should be no physical, psychological, social or legal risks associated with this study. No invasive procedures are recommended or requested. * All appropriate and necessary procedures will be utilized to maintain confidentiality. All patients who have had samples submitted for analysis will have their CALGB ID number used to identify specimens. * This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated. It is likely, however, tIt is likely, however, that the information gained will substantially help similar patients in the future.

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51102, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Minetta C. Liu, MD

  Lombardi Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: October 1, 2000
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

US (3)