Status:
COMPLETED
Biomarkers in Blood Samples From Older Breast Cancer Survivors
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Brief Summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how we...
Detailed Description
OBJECTIVES: Primary * To measure and compare normalized p16\^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery wit...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Stage I-III disease
- Breast cancer survivors meeting 1 of the following criteria:
- Prior surgery with or without (±) radiotherapy (RT) (cohort 1)
- Prior surgery ± RT, followed by prior or concurrent hormonal (endocrine) therapy (cohort 2)
- Must have received or be on endocrine therapy for ≥ 3 months
- Prior surgery ± RT, followed by prior chemotherapy ± endocrine therapy (cohort 3)
- No recurrent disease
- No history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia)
- PATIENT CHARACTERISTICS:
- Life expectancy \> 12 months
- Absolute lymphocyte count \> 500/μL
- No acute or active infection
- No other co-morbid illness that would impair ability to participate in the study
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 months since prior surgery with or without radiotherapy
- At least 3 months since prior chemotherapy (cohort 3)
- No concurrent radiotherapy, chemotherapy, or experimental therapy
Exclusion
Key Trial Info
Start Date :
January 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT01138345
Start Date
January 1 2010
End Date
February 1 2014
Last Update
February 27 2014
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295