Status:
COMPLETED
Gene Expression Profiling and Genetic Analysis of Tissues From Patients With Breast Cancer
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
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...
Detailed Description
PRIMARY OBJECTIVES: 1. To determine if amplification and/or overexpression of erbB-2 is associated with either additional or less benefit from increasing doses of doxorubicin or four cycles of paclit...
Eligibility Criteria
Inclusion
- Registration to CALGB 9344 or 9741
- Samples collected, shipped and stored appropriately at the CALGB Pathology Coordinating Office
- Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required.
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00899509
Start Date
October 1 2000
End Date
February 1 2011
Last Update
August 8 2017
Active Locations (3)
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1
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
2
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
3
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104